CompletedNCT00977938Updated Jun 9, 2017Results posted

The Dual Antiplatelet Therapy Study (DAPT Study)

A Phase 4 interventional study of Placebo & Aspirin and Clopidogrel & Aspirin, Prasugrel & Aspirin in Coronary Artery Disease, sponsored by Baim Institute for Clinical Research. Completed at 256 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-09.

Sponsored by Baim Institute for Clinical Research · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 25,682
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

Read the detailed description

Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with stent placement and no contraindications to prolonged dual antiplatelet therapy are eligible to be enrolled in the study.

All enrolled subjects will undergo PCI with stent placement. All enrolled subjects will be treated with either an FDA-approved drug eluting stent(s) (DES) or an FDA-approved bare metal stent(s) (BMS) (per their respective Instructions for Use) and assigned to 12 months of open label FDA-approved thienopyridine treatment in addition to aspirin. Operators will select the thienopyridine according to the package insert. Thienopyridine treatment dose will be according to the standard of practice and prescribing information for the selected medication. Aspirin treatment will be 75-325 mg for the first 6 months after the procedure and 75-162 mg subsequently, to be continued indefinitely. All DES or BMS subjects who are treated with 12 months of dual antiplatelet therapy post index procedure and who are event free per protocol will be eligible for randomization to either placebo (12 m DAPT Study arm) or an additional 18 months of thienopyridine treatment (30 m DAPT Study arm). Both arms will continue aspirin therapy.

Up to four (4) separate post-market approval studies will be allowed to incorporate the randomized design of the DAPT Study for a subset of subjects who may then be contributed for the DAPT Study analyses.

Conditions studied

Coronary Artery Disease

Browse trials for

Coronary Artery Disease 5,587

Keywords

Acute Coronary Syndrome
Adverse event
Antiplatelet therapy
Sirolimus
Everolimus
Paclitaxel
Zotarolimus
Bare Metal Stent
Drug Eluting Stent
Clinical Events Committee
Dual antiplatelet therapy
Harvard Clinical Research Institute
Major Adverse Cardiac and Cerebral Event
Major Bleeding
Myocardial infarction
Myocardial ischemia
Percutaneous coronary intervention
Stent placement
Stent Thrombosis
Thienopyridine
Clopidogrel
Prasugrel

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria (Enrollment):

Subject is > 18 years of age.
Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.

Inclusion Criterion (Randomization at 12 months):

Subject, at 12 months, is free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis and has been compliant with dual antiplatelet therapy following stent implantation.

Exclusion Criteria (Enrollment):

Index procedure stent placement with stent diameter \<2.25 mm or >4.0 mm.
Pregnant women.
Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.
Current medical condition with a life expectancy of less than 3 years.
Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices. The subject may only be enrolled in the DAPT Study once.
Subjects on warfarin or similar anticoagulant therapy.
Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.
Subjects unable to give informed consent.
Subject treated with both DES and BMS during the index procedure.

Exclusion Criteria (Randomization at 12 months):

Pregnant women.
Subject switched thienopyridine type or dose within 6 months prior to randomization.
Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
Current medical condition with a life expectancy of less than 3 years.
Subjects on warfarin or similar anticoagulant therapy.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 25,682 participants (actual)

Study arms

Placebo comparator
12m DAPT Study Arm
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
Drug: Placebo & Aspirin
Active comparator
30m DAPT Study Arm
This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine treatment in addition to aspirin.
Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

Interventions

DrugPlacebo & Aspirin
DrugClopidogrel & Aspirin, Prasugrel & Aspirin

What researchers measure

Primary outcomes

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.
Time frame: 18 months (12-30 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 18 months (12-30 months post-index procedure)
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 18 months (12-30 months post-index procedure)

Secondary outcomes

MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
Secondary powered endpoint
Time frame: 33 months (0-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
Secondary powered endpoint
Time frame: 33 months (0-33 months post-index procedure)
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
Time frame: 21 months (12-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 21 months (12-33 months post-index procedure)
GUSTO Severe or Moderate Bleeding - Randomized DES ITT
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 21 months (12-33 months post-index procedure)
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Time frame: 18 months (12-30 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 18 months (12-30 months post-index procedure)
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 18 months (12-30 months post-index procedure)
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
Time frame: 21 months (12-33 months post-index procedure)
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
ST was assessed according to the Academic Research Consortium (ARC) definitions.
Time frame: 21 months (12-33 months post-index procedure)
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.
Time frame: 21 months (12-33 months post-index procedure)

Results

Posted Oct 22, 2015

Participant flow

Between 08/13/2009 and 07/01/2011, a total of 25682 patients were enrolled into the DAPT Study either by HCRI (NCT00977938; 14491 pts) or from 1 of 4 PMS studies: Abbott Xience V US (NCT01106534; 2998 pts), Boston Scientific Liberté PAS (NCT00997503; 3904 pts), Cordis CYPRESS (NCT00954707; 2029 pts) and Medtronic EDUCATE (NCT01069003; 2260 pts).

Treatment (12-30 mo. Post Procedure)

Participant flow — Treatment (12-30 mo. Post Procedure)
Milestone	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT
Started	5020	4941	842	845
Completed	4783	4716	796	784
Not completed	237	225	46	61
Withdrew: Withdrawal by subject	132	116	13	20
Withdrew: Lost to follow-up	88	91	30	37
Withdrew: Other	17	18	3	4

Observation (30-33 mo. Post Procedure)

Participant flow — Observation (30-33 mo. Post Procedure)
Milestone	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT
Started	4783	4716	796	784
Completed	4732	4658	784	781
Not completed	51	58	12	3
Withdrew: Withdrawal by subject	9	12	2	0
Withdrew: Lost to follow-up	34	42	10	3
Withdrew: Other	8	4	0	0

Outcome measures

PrimaryMACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.

Time frame:: 18 months (12-30 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
percentage of patients (KM estimate)	DES 30-month DAPT	DES 12-month DAPT
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT	4.34	5.92

Statistical analysis

DES 30-month DAPT vs DES 12-month DAPT · Log Rank · p = <0.001 (P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.) · Hazard ratio (hr): 0.71 · 95% CI 0.59 to 0.8530-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.

PrimaryDefinite or Probable Stent Thrombosis (ST) - Randomized DES ITT

The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.

Time frame:: 18 months (12-30 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
percentage of patients (KM estimate)	DES 30-month DAPT	DES 12-month DAPT
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT	0.40	1.35

Statistical analysis

DES 30-month DAPT vs DES 12-month DAPT · Log Rank · p = <0.001 (P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.) · Hazard ratio (hr): 0.29 · 95% CI 0.17 to 0.4830-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.

PrimaryGUSTO Severe or Moderate Bleeding - Randomized DES ITT

The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

Time frame:: 18 months (12-30 months post-index procedure)
Reported as:: Number · percentage of patients

GUSTO Severe or Moderate Bleeding - Randomized DES ITT
percentage of patients	DES 30-month DAPT	DES 12-month DAPT
GUSTO Severe or Moderate Bleeding - Randomized DES ITT	2.53	1.57

Statistical analysis

DES 30-month DAPT vs DES 12-month DAPT · Farrington-Manning · p = 0.704 (One-sided P-value for non-inferiority) · Risk difference (rd): 0.96 · 95% CI 0.38 to 1.5330-month DAPT vs. 12-month DAPT

SecondaryMACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS

Secondary powered endpoint

Time frame:: 33 months (0-33 months post-index procedure)
Reported as:: Number · percentage of patients

MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
percentage of patients	Propensity-matched DES	Propensity-matched BMS
MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS	11.37	13.24

Statistical analysis

Propensity-matched DES vs Propensity-matched BMS · Nam and Kwon · p = <0.001 (One-sided P-value for non-inferiority) · Risk difference (rd): -1.82Weighted RD and 1-sided 97.5% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).

SecondaryDefinite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS

Secondary powered endpoint

Time frame:: 33 months (0-33 months post-index procedure)
Reported as:: Number · percentage of patients

Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
percentage of patients	Propensity-matched DES	Propensity-matched BMS
Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS	1.70	2.61

Statistical analysis

Propensity-matched DES vs Propensity-matched BMS · Nam and Kwon · p = <0.001 (One-sided P-value for non-inferiority) · Risk difference (rd): -1.05Weighted RD and 1-sided 95% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).

SecondaryMACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT

Time frame:: 21 months (12-33 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
percentage of patients (KM estimate)	DES 30-month DAPT	DES 12-month DAPT
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT	5.62	6.49

Statistical analysis

DES 30-month DAPT vs DES 12-month DAPT · Hazard ratio (hr): 0.82 · 95% CI 0.70 to 0.9730-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis

SecondaryDefinite or Probable Stent Thrombosis (ST) - Randomized DES ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions.

Time frame:: 21 months (12-33 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
percentage of patients (KM estimate)	DES 30-month DAPT	DES 12-month DAPT
Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT	0.69	1.45

Statistical analysis

DES 30-month DAPT vs DES 12-month DAPT · Hazard ratio (hr): 0.45 · 95% CI 0.29 to 0.6930-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis

SecondaryGUSTO Severe or Moderate Bleeding - Randomized DES ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

Time frame:: 21 months (12-33 months post-index procedure)
Reported as:: Number · percentage of patients

GUSTO Severe or Moderate Bleeding - Randomized DES ITT
percentage of patients	DES 30-month DAPT	DES 12-month DAPT
GUSTO Severe or Moderate Bleeding - Randomized DES ITT	2.74	1.88

Statistical analysis

DES 30-month DAPT vs DES 12-month DAPT · Risk difference (rd): 0.86 · 95% CI 0.24 to 1.4830-month DAPT vs. 12-month DAPT

SecondaryMACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

Time frame:: 18 months (12-30 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
percentage of patients (KM estimate)	BMS 30-month DAPT	BMS 12-month DAPT
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT	4.04	4.69

Statistical analysis

BMS 30-month DAPT vs BMS 12-month DAPT · Log Rank · p = 0.722 (This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.) · Hazard ratio (hr): 0.92 · 95% CI 0.57 to 1.4730-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.

SecondaryDefinite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions.

Time frame:: 18 months (12-30 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
percentage of patients (KM estimate)	BMS 30-month DAPT	BMS 12-month DAPT
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT	0.50	1.11

Statistical analysis

BMS 30-month DAPT vs BMS 12-month DAPT · Log Rank · p = 0.478 (This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.) · Hazard ratio (hr): 0.49 · 95% CI 0.15 to 1.6430-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.

SecondaryGUSTO Severe or Moderate Bleeding - Randomized BMS ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

Time frame:: 18 months (12-30 months post-index procedure)
Reported as:: Number · percentage of patients

GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
percentage of patients	BMS 30-month DAPT	BMS 12-month DAPT
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT	2.03	0.90

Statistical analysis

BMS 30-month DAPT vs BMS 12-month DAPT · Farrington-Manning · p = 0.706 · Risk difference (rd): 1.12 · 95% CI -0.06 to 2.3130-month DAPT vs. 12-month DAPT

SecondaryMACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT

Time frame:: 21 months (12-33 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
percentage of patients (KM estimate)	BMS 30-month DAPT	BMS 12-month DAPT
MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT	4.68	5.48

Statistical analysis

BMS 30-month DAPT vs BMS 12-month DAPT · Hazard ratio (hr): 0.91 · 95% CI 0.58 to 1.4030-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis

SecondaryDefinite or Probable Stent Thrombosis (ST) - Randomized BMS ITT

ST was assessed according to the Academic Research Consortium (ARC) definitions.

Time frame:: 21 months (12-33 months post-index procedure)
Reported as:: Number · percentage of patients (KM estimate)

Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
percentage of patients (KM estimate)	BMS 30-month DAPT	BMS 12-month DAPT
Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT	0.50	1.11

Statistical analysis

BMS 30-month DAPT vs BMS 12-month DAPT · Hazard ratio (hr): 0.49 · 95% CI 0.15 to 1.6430-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.

SecondaryGUSTO Severe or Moderate Bleeding - Randomized BMS ITT

Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.

Time frame:: 21 months (12-33 months post-index procedure)
Reported as:: Number · percentage of patients

GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
percentage of patients	BMS 30-month DAPT	BMS 12-month DAPT
GUSTO Severe or Moderate Bleeding - Randomized BMS ITT	2.09	1.05

Statistical analysis

BMS 30-month DAPT vs BMS 12-month DAPT · Risk difference (rd): 1.03 · 95% CI -0.21 to 2.2830-month DAPT vs. 12-month DAPT

Adverse events

Collected over 12-33 months post-index procedure (randomization to 33 months post-index procedure). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
HCRI DAPT - DES 30-month DAPT	—	617/2,642 (23.4%)	—
HCRI DAPT - DES 12-month DAPT	—	572/2,634 (21.7%)	—
HCRI DAPT - BMS 30-month DAPT	—	144/842 (17.1%)	—
HCRI DAPT - BMS 12-month DAPT	—	150/845 (17.8%)	—

Most frequent serious events

Showing 10 of 526

Most frequent serious events
Event	HCRI DAPT - DES 30-month DAPT	HCRI DAPT - DES 12-month DAPT	HCRI DAPT - BMS 30-month DAPT	HCRI DAPT - BMS 12-month DAPT
ANGINA PECTORISCardiac disorders	55/2642	55/2634	13/842	18/845
NON-CARDIAC CHEST PAINGeneral disorders	54/2642	51/2634	12/842	15/845
CHEST PAINGeneral disorders	43/2642	45/2634	12/842	7/845
ANGINA UNSTABLECardiac disorders	27/2642	40/2634	4/842	5/845
OSTEOARTHRITISMusculoskeletal and connective tissue disorders	29/2642	25/2634	7/842	5/845
CORONARY ARTERY DISEASECardiac disorders	22/2642	16/2634	9/842	6/845
ATRIAL FIBRILLATIONCardiac disorders	24/2642	14/2634	3/842	9/845
CARDIAC FAILURE CONGESTIVECardiac disorders	22/2642	14/2634	4/842	5/845
SYNCOPENervous system disorders	10/2642	9/2634	7/842	3/845
PNEUMONIAInfections and infestations	21/2642	17/2634	4/842	4/845

Most frequent other events

Most frequent other events
Event	HCRI DAPT - DES 30-month DAPT	HCRI DAPT - DES 12-month DAPT	HCRI DAPT - BMS 30-month DAPT	HCRI DAPT - BMS 12-month DAPT
AEs were not collected in the DAPT TrialCardiac disorders	—	—	—	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
Mean	61.84 ± 10.18	61.60 ± 10.12	58.86 ± 10.54	59.18 ± 11.07	61.33 ± 10.29

Sex: Female, Male
Sex: Female, Male(Participants)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
Female	1242	1284	215	184	2925
Male	3778	3657	627	661	8723

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
American Indian or Alaska Native	17	41	0	2	60
Asian	48	35	3	2	88
Black or African American	252	253	38	33	576
Native Hawaiian or Other Pacific Islander	13	9	1	1	24
White	4480	4428	768	774	10450
Other	108	106	20	23	257

Region of Enrollment
Region of Enrollment(participants)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
North America	4502	4416	509	519	9946
Europe	402	405	304	300	1411
Australia	47	55	14	12	128
New Zealand	69	65	15	14	163

weight
weight(kg)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
Mean	91.49 ± 19.74	91.52 ± 19.43	87.99 ± 18.40	88.54 ± 18.77	91.04 ± 19.48

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
Mean	30.54 ± 5.79	30.55 ± 5.77	29.49 ± 5.18	29.61 ± 5.55	30.40 ± 5.73

Diabetes Mellitus
Diabetes Mellitus(participants)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
Number	1556	1481	181	173	3391

Hypertension
Hypertension(participants)	DES 30-month DAPT	DES 12-month DAPT	BMS 30-month DAPT	BMS 12-month DAPT	Total
Number	3796	3649	534	543	8522

16 further baseline measures are reported on the registry.

Study locations

256 sites

Thomas Hospital
Fairhope, Alabama 36532, United States
Mercy Gilbert Medical Center
Gilbert, Arizona 85297, United States
Heart & Vascular Center of Arizona
Phoenix, Arizona 85006, United States
Scottsdale Health Care
Scottsdale, Arizona 85258, United States
NEA Baptist Clinic
Jonesboro, Arkansas 72401, United States
University of Arkansas (Central VA) for Medical Science
Little Rock, Arkansas 72205, United States
Arkansas Heart Hospital
Little Rock, Arkansas 72211, United States
California Cardiovascular Consultants/ Washington Hospital
Fremont, California 94538, United States
The Foundation for Cardiovascular Medicine
La Jolla, California 92037, United States
Mercy General Hospital
Sacramento, California 95819, United States
UC San Diego Medical Center
San Diego, California 92103-8784, United States
California Pacific Medical Center
San Francisco, California 94115, United States
St. Joseph's Medical Center- CA
Stockton, California 95204-6088, United States
Torrance Memorial Medical Center / Vasek Polak Research Program
Torrance, California 90505, United States
Harbor - UCLA Medical Center
Torrance, California 90509, United States
Medical Center of Aurora
Aurora, Colorado 80012, United States
Connecticut Clinical Research, LLC
Bridgeport, Connecticut 06606, United States
Bridgeport Hospital
Bridgeport, Connecticut 06610, United States
St. Vincent's Medical Center
Stamford, Connecticut 06905, United States
Washington Hospital Center
Washington, D.C., District of Columbia 20010, United States
Palm Beach Heart Research Institute
Atlantis, Florida 33462, United States
Bay Area Cardiology Associates/ Brandon Regional Hospital
Brandon, Florida 33511, United States
Jacksonville Heart Center
Jacksonville, Florida 32207, United States
Watson Clinic Center for Research
Lakeland, Florida 33805, United States
Diagnostic Cardiology Associates
Lauderdale Lakes, Florida 33313, United States
Melbourne Internal Medicine Assoc
Melbourne, Florida 32901, United States
Baptist Hospital of Miami
Miami, Florida 33176, United States
Munroe Regional Medical Center
Ocala, Florida 34471, United States
Ocala Regional Medical Center
Ocala, Florida 34480, United States
Florida Hospital
Orlando, Florida 32803, United States
Baptist Hospital
Pensacola, Florida 32501, United States
Sacred Heart Hospital
Pensacola, Florida 32504, United States
Tallahassee Memorial Hospital
Tallahassee, Florida 32308, United States
Pepin Heart Hospital
Tampa, Florida 33613, United States
Winter Haven Hospital
Winter Haven, Florida 33881, United States
Emory University Hospital Midtown
Atlanta, Georgia 30308, United States
Piedmont Hospital Research Institute
Atlanta, Georgia 30309, United States
Emory University Hospital
Atlanta, Georgia 30322, United States
Medical Center Central Georgia
Macon, Georgia 31201, United States
Redmond Regional Hospital
Rome, Georgia 30165, United States
Advocate Good Shephard Hospital
Barrington, Illinois 60010, United States
Jesse Brown VA Medical Center
Chicago, Illinois 60612, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
University of Illinois at Chicago
Chicago, Illinois 60612, United States
Good Samaritan Hospital- IL
Downers Grove, Illinois 60515, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois 60126, United States
Heartland Education and Research Foundation
Joliet, Illinois 60435, United States
Loyola University Medical Center
Maywood, Illinois 60153, United States
Heart Care Research Foundation
Mokena, Illinois 60448, United States
Edward Heart Hospital
Naperville, Illinois 60540, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana 46541, United States
St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana 46290, United States
Northwest Indiana Cardiovascular Physicians, P.C.
Valparaiso, Indiana 46383, United States
McFarland Clinic PC
Ames, Iowa 50010, United States
St. Luke's Hospital - Cedar Rapids
Cedar Rapids, Iowa 52403, United States
Iowa Heart Center
West Des Moines, Iowa 50266, United States
Kings Daughters Medical Center
Ashland, Kentucky 41101, United States
Tulane University Medical School
New Orleans, Louisiana 70112, United States
Northeast Cardiology Associates
Bangor, Maine 04401, United States
Maine Medical Center
Portland, Maine 04102, United States
Sinai Hospital at Baltimore
Baltimore, Maryland 21215, United States
Union Memorial Hospital
Baltimore, Maryland 21218, United States
Shah Associates, LLC
Prince Frederick, Maryland 20678, United States
Peninsula Regional Medical Center
Salisbury, Maryland 21804, United States
Washington Adventist Hospital
Takoma Park, Maryland 20912, United States
Brigham and Women's Hospital
Boston, Massachusetts 02115, United States
Boston Medical Center
Boston, Massachusetts 02118, United States
Brigham and Women's Hospital
Boston, Massachusetts 02120, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
Lahey Clinic Medical Center
Burlington, Massachusetts 01805, United States
Cape Cod Hospital
Hyannis, Massachusetts 02601, United States
UMass Memorial Medical Center
Worcester, Massachusetts 01655, United States
Bay Regional Medical Center
Bay City, Michigan 48708, United States
Harper University Hospital
Detroit, Michigan 48201-2018, United States
Henry Ford Hospital Heart & Vascular Institute
Detroit, Michigan 48202, United States
Borgess Medical Center
Kalamazoo, Michigan 49048, United States
St. Joseph Mercy-PTCMI
Pontiac, Michigan 48341, United States
William Beaumont Hospital
Royal Oak, Michigan 48073-6769, United States
Covenant Medical Center
Saginaw, Michigan 48602, United States
Great Lakes Heart & Vascular Institute, PC
Saint Joseph, Michigan 49085, United States
Munson Medical Center
Traverse City, Michigan 49684, United States
Beaumont Hospital Troy
Troy, Michigan 48085, United States
Mayo Clinic - Saint Marys Hospital
Rochester, Minnesota 55905, United States
Central Minnesota Heart Center at St. Cloud Hospital
Saint Cloud, Minnesota 56303, United States
Hattiesburg Clinic
Hattiesburg, Mississippi 39401, United States
Cardiology Associates Research LLC
Tupelo, Mississippi 38801, United States
St. Luke's Hospital Mid America Heart Institute
Kansas City, Missouri 64111, United States
Kansas City Heart Foundation
Kansas City, Missouri 64114, United States
North Kansas City Hospital
North Kansas City, Missouri 64116, United States
Washington University Hospital
Saint Louis, Missouri 63110-1093, United States
St. Louis University Hospital
Saint Louis, Missouri 63110, United States
St. John's Mercy Medical Center
Saint Louis, Missouri 63141, United States
St. John's Medical Institute
Springfield, Missouri 65807, United States
Nebraska Heart Institute
Lincoln, Nebraska 68526, United States
Alegent Health / Bergan Mercy Hospital
Omaha, Nebraska 68124, United States
Creighton University
Omaha, Nebraska 68131, United States
Catholic Medical Center
Manchester, New Hampshire 03102, United States
Cooper University Hospital
Camden, New Jersey 08103, United States
Cardiovascular Associates of the Delaware Valley, PA
Haddon Heights, New Jersey 08035, United States
Hamilton Cardiology Associates
Hamilton, New Jersey 08690, United States

Showing the first 100 of 256 sites across 10 countries.

References and documents

Publications

Berg DD, Yeh RW, Mauri L, Morrow DA, Kereiakes DJ, Cutlip DE, Gao Q, Jarolim P, Michelson AD, Frelinger AL 3rd, Cange AL, Sabatine MS, O'Donoghue ML. Biomarkers of platelet activation and cardiovascular risk in the DAPT trial. J Thromb Thrombolysis. 2021 Apr;51(3):675-681. doi: 10.1007/s11239-020-02221-5. PubMed 32683645 ↗
Stefanescu Schmidt AC, Steg PG, Yeh RW, Kereiakes DJ, Tanguay JF, Hsieh WH, Massaro JM, Mauri L, Cutlip DE; DAPT Investigators. Interruption of Dual Antiplatelet Therapy Within Six Months After Coronary Stents (from the Dual Antiplatelet Therapy Study). Am J Cardiol. 2019 Dec 15;124(12):1813-1820. doi: 10.1016/j.amjcard.2019.09.006. Epub 2019 Sep 26. PubMed 31653353 ↗
Berry NC, Kereiakes DJ, Yeh RW, Steg PG, Cutlip DE, Jacobs AK, Abbott JD, Hsieh WH, Massaro JM, Mauri L; DAPT Study Investigators. Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e005308. doi: 10.1161/CIRCINTERVENTIONS.117.005308. PubMed 30354781 ↗
Yeh RW, Kereiakes DJ, Steg PG, Cutlip DE, Croce KJ, Massaro JM, Mauri L; DAPT Study Investigators. Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Oct 31;70(18):2213-2223. doi: 10.1016/j.jacc.2017.09.011. PubMed 29073947 ↗
Secemsky EA, Yeh RW, Kereiakes DJ, Cutlip DE, Cohen DJ, Steg PG, Cannon CP, Apruzzese PK, D'Agostino RB Sr, Massaro JM, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. JAMA Cardiol. 2017 May 1;2(5):478-487. doi: 10.1001/jamacardio.2017.0063. PubMed 28297015 ↗
Stefanescu Schmidt AC, Kereiakes DJ, Cutlip DE, Yeh RW, D'Agostino RB Sr, Massaro JM, Hsieh WH, Mauri L; DAPT Investigators. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). Circulation. 2017 May 2;135(18):1720-1732. doi: 10.1161/CIRCULATIONAHA.116.024835. Epub 2017 Feb 22. PubMed 28228427 ↗
Resor CD, Nathan A, Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Gabriel Steg P, Hsieh WH, Mauri L; Dual Antiplatelet Therapy Study Investigators. Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation. 2016 Oct 4;134(14):989-998. doi: 10.1161/CIRCULATIONAHA.116.024531. Epub 2016 Aug 30. PubMed 27576774 ↗
Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Steg PG, Wiviott SD, Mauri L; DAPT Study Investigators. DAPT Score Utility for Risk Prediction in Patients With or Without Previous Myocardial Infarction. J Am Coll Cardiol. 2016 May 31;67(21):2492-502. doi: 10.1016/j.jacc.2016.03.485. Epub 2016 Apr 1. PubMed 27046159 ↗
Yeh RW, Secemsky EA, Kereiakes DJ, Normand SL, Gershlick AH, Cohen DJ, Spertus JA, Steg PG, Cutlip DE, Rinaldi MJ, Camenzind E, Wijns W, Apruzzese PK, Song Y, Massaro JM, Mauri L; DAPT Study Investigators. Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA. 2016 Apr 26;315(16):1735-49. doi: 10.1001/jama.2016.3775. Erratum In: JAMA. 2016 Jul 19;316(3):350. doi: 10.1001/jama.2016.6123. JAMA. 2016 Jul 19;316(3):350. doi: 10.1001/jama.2016.9558. PubMed 27022822 ↗
Meredith IT, Tanguay JF, Kereiakes DJ, Cutlip DE, Yeh RW, Garratt KN, Lee DP, Steg PG, Weaver WD, Holmes DR Jr, Brindis RG, Trebacz J, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Diabetes Mellitus and Prevention of Late Myocardial Infarction After Coronary Stenting in the Randomized Dual Antiplatelet Therapy Study. Circulation. 2016 May 3;133(18):1772-82. doi: 10.1161/CIRCULATIONAHA.115.016783. Epub 2016 Mar 18. Erratum In: Circulation. 2016 May 31;133(22):e671. doi: 10.1161/CIR.0000000000000430. PubMed 26994121 ↗
Hermiller JB, Krucoff MW, Kereiakes DJ, Windecker S, Steg PG, Yeh RW, Cohen DJ, Cutlip DE, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. JACC Cardiovasc Interv. 2016 Jan 25;9(2):138-47. doi: 10.1016/j.jcin.2015.10.001. PubMed 26793956 ↗
Mauri L, Elmariah S, Yeh RW, Cutlip DE, Steg PG, Windecker S, Wiviott SD, Cohen DJ, Massaro JM, D'Agostino RB Sr, Braunwald E, Kereiakes DJ; DAPT Study Investigators. Causes of late mortality with dual antiplatelet therapy after coronary stents. Eur Heart J. 2016 Jan 21;37(4):378-85. doi: 10.1093/eurheartj/ehv614. Epub 2015 Nov 18. PubMed 26586780 ↗
Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; DAPT Study Investigators. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. JACC Cardiovasc Interv. 2015 Oct;8(12):1552-62. doi: 10.1016/j.jcin.2015.05.026. Erratum In: JACC Cardiovasc Interv. 2015 Dec 21;8(14):1913. PubMed 26493248 ↗
Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction. J Am Coll Cardiol. 2015 May 26;65(20):2211-21. doi: 10.1016/j.jacc.2015.03.003. Epub 2015 Mar 15. PubMed 25787199 ↗
Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial. JAMA. 2015 Mar 17;313(11):1113-21. doi: 10.1001/jama.2015.1671. Erratum In: JAMA. 2015 Jun 2;313(21):2185. doi: 10.1001/jama.2015.4806. JAMA. 2016 Jul 5;316(1):105. doi: 10.1001/jama.2016.8640. JAMA. 2016 Jul 5;316(1):105. doi: 10.1001/jama.2016.8646. PubMed 25781440 ↗
Yeh RW, Czarny MJ, Normand SL, Kereiakes DJ, Holmes DR Jr, Brindis RG, Weaver WD, Rumsfeld JS, Roe MT, Kim S, Driscoll-Shempp P, Mauri L. Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):96-102. doi: 10.1161/CIRCOUTCOMES.114.001239. Epub 2014 Nov 16. PubMed 25399847 ↗
Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16. PubMed 25399658 ↗
Matteau A, Yeh RW, Kereiakes D, Orav EJ, Massaro J, Steg PG, Normand SL, Cutlip DE, Mauri L. Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study). Am J Cardiol. 2014 Apr 1;113(7):1146-52. doi: 10.1016/j.amjcard.2013.10.015. Epub 2013 Nov 8. PubMed 24332248 ↗
Mauri L, Kereiakes DJ, Normand SL, Wiviott SD, Cohen DJ, Holmes DR, Bangalore S, Cutlip DE, Pencina M, Massaro JM. Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions. Am Heart J. 2010 Dec;160(6):1035-41, 1041.e1. doi: 10.1016/j.ahj.2010.07.038. PubMed 21146655 ↗

Registry details

Key details

Study ID: NCT00977938
Lead sponsor: Baim Institute for Clinical Research
Collaborators: Abbott, Boston Scientific Corporation, Bristol-Myers Squibb, Sanofi-Synthelabo, Cordis Corporation, Eli Lilly and Company, Daiichi Sankyo, Medtronic
Responsible party: Sponsor
First posted: Sep 16, 2009
Start date: Oct 2009
Primary completion: Jun 2014
Completion: Jun 2014
Results posted: Oct 22, 2015
Last update: Jun 9, 2017

Study contacts

Laura Mauri, MD, MSc

principal investigator · Brigham and Women's Hospital

Dean Kereiakes, MD, FACC

principal investigator · Christ Hospital Heart and Vascular Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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