CClinicalTrials.gg
Sign In
Status unknownNCT01701453SMART-DATEUpdated Feb 8, 2018

Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)

An interventional study of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) in Acute Coronary Syndrome, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-02-08.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,712
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

  1. Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT) compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).
  2. Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in patients with ACS.
Read the detailed description

  1. Primary endpoint

    • MACCE, defined as a composite of all-cause mortality, myocardial infarction, and cerebrovascular events at 18 months after the index procedure.

  2. Secondary endpoint

    • Individual components of the primary endpoint at 18-month after the index procedure
    • Definite/probable stent thrombosis, defined by the Academic Research Consortium (ARC) at 18-month after the index procedure.
    • Bleeding complication, defined by Bleeding Academic Research Consortium (BARC) type 2 to 5 at 18-month after the index procedure.
02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • duration of DAPT
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 2,712 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject must be ≥ 20 years.
  2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving percutaneous coronary intervention and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  3. Subject must have a culprit lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation.
  4. Subject must have clinical diagnosis of ACS that includes unstable angina and MI. The specific definitions of ACS, as follows; 1) ST-segment elevation MI (STEMI) : elevation of ST-segment more than 0.1 mV in 2 or more contiguous electrocardiographic (ECG) leads or new left bundle-branch block with elevated biomarkers of myocardial necrosis 2) Non-ST-segment elevation MI (NSTEMI) : Elevated biomarkers of myocardial necrosis (troponin or CK-MB > upper reference limit) with one of the following; (a) Transient ST-segment elevation or depression, or T-wave changes consistent with myocardial ischemia, (b) Identification of a culprit lesion at coronary angiography 3) Unstable angina : An accelerating pattern or recurrent episodes of chest pain at rest or with minimal effort and new ST-segment depression of at least 0.05 mV, or T wave inversion of at least 0.3 mV in at least 2 leads. The ECG criteria for unstable angina were based on the TACTICS-TIMI 18 trial.
  5. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
  6. Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion criteria

Exclusion Criteria:

  1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus, Everolimus, Zotarolimus, and Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
  2. Patients with active pathologic bleeding
  3. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  4. Systemic (intravenous) Biolimus, everolimus, zotarolimus use within 12 months.
  5. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  6. History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
  7. Noncardiac comorbid conditions are present with life expectancy \<1 year or that may result in protocol noncompliance (per site investigator's medical judgment).
  8. An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
  9. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,712 participants (actual)

Study arms

  • Experimental
    6 months group

    6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment

    Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

  • Experimental
    12 months or longer group

    12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment

    Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Interventions

  • DrugP2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

    P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

06

What researchers measure

Primary outcomes

  1. A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event

    defined as MACCE

    Time frame: at 18-month after the index procedure

Secondary outcomes

  1. All-cause mortality

    Individual component of MACCE

    Time frame: at 18-month after the index procedure

  2. Spontaneous MI

    Individual component of MACCE

    Time frame: at 18-month after the index procedure

  3. Cerebrovascular event

    Individual component of MACCE

    Time frame: at 18-month after the index procedure

  4. Stent thrombosis

    Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)

    Time frame: at 18-month after the index procedure

  5. Bleeding

    Bleeding Academic Research Consortium (BARC) type 2 to 5

    Time frame: at 18-month after the index procedure

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

References and documents

Publications

  • Song PS, Park YH, Oh JH, Song YB, Choi SH, Gwon HC, Cho DK, Rha SW, Bae JW, Jeong JO, Hahn JY; SMART-DATE and the SMART-CHOICE investigators. P2Y12 Inhibitor Monotherapy Versus Conventional Dual Antiplatelet Therapy or Aspirin Monotherapy in Acute Coronary Syndrome: A Pooled Analysis of the SMART-DATE and SMART-CHOICE Trials. Am J Cardiol. 2021 Jul 1;150:47-54. doi: 10.1016/j.amjcard.2021.03.053. Epub 2021 May 16. PubMed 34011436 ↗
  • Kedhi E, Delewi R, Fabris E, De Luca G, Hermanides RS, van den Ent M, Buszman P, Zijlstra F, Song YB, Gwon HC, Hahn JY. Duration of dual antiplatelet therapy after myocardial infarction: Insights from a pooled database of the SMART-DATE and DAPT-STEMI trials. Atherosclerosis. 2020 Dec;315:55-61. doi: 10.1016/j.atherosclerosis.2020.11.003. Epub 2020 Nov 9. PubMed 33227548 ↗
  • Choi KH, Song YB, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Oh JH, Cho DK, Lee JB, Doh JH, Kim SH, Jeong JO, Bae JH, Kim BO, Cho JH, Suh IW, Kim DI, Park HK, Park JS, Choi WG, Lee WS, Gwon HC, Hahn JY. Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial. Circ Cardiovasc Interv. 2020 May;13(5):e008530. doi: 10.1161/CIRCINTERVENTIONS.119.008530. Epub 2020 May 1. PubMed 32354228 ↗
  • Hahn JY, Song YB, Oh JH, Cho DK, Lee JB, Doh JH, Kim SH, Jeong JO, Bae JH, Kim BO, Cho JH, Suh IW, Kim DI, Park HK, Park JS, Choi WG, Lee WS, Kim J, Choi KH, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Gwon HC; SMART-DATE investigators. 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial. Lancet. 2018 Mar 31;391(10127):1274-1284. doi: 10.1016/S0140-6736(18)30493-8. Epub 2018 Mar 12. PubMed 29544699 ↗

Individual participant data

Plan to share: Yes — After publication of first manuscript

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01701453
Lead sponsor
Samsung Medical Center
Responsible party
Hyeon-Cheol Gwon (Professor, Samsung Medical Center) — Principal investigator
First posted
Oct 5, 2012
Start date
Aug 2012
Primary completion
Nov 2017
Completion
Nov 2019 (estimated)
Last update
Feb 8, 2018

Study contacts

Hyeon-Cheol Gwon, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acute Coronary Syndrome→

Other studies from this sponsor

Samsung Medical Center

Start the discussion