Status unknownNCT00954707Updated Feb 7, 2014Results posted

CYPRESS - CYPHER for Evaluating Sustained Safety

A Phase 4 interventional study of Clopidogrel & Aspirin, Prasugrel & Aspirin and Placebo & Aspirin in Coronary Artery Disease, sponsored by Cordis Corporation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-07.

Sponsored by Cordis Corporation · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 2,509
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

CYPRESS: A Prospective,Randomized,Multi-Center,Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent)

Read the detailed description

During Phase I (non-randomized phase) of this study, the primary objective is to assess the rate of target lesion failure in subjects implanted with the CYPHER® stent and receiving dual antiplatelet therapy for 12 months.

During Phase II (randomized phase) of this study, the primary objective is to assess safety (major and minor bleeding), MACCE, and ST rates in subjects treated with dual antiplatelet therapy for 12 or 30 months following CYPHER® stent implantation.

*Subjects treated with the CYPHER® 2.25mm stent will be followed through 60 months.

**The last 500 patients enrolled will not be eligible for randomization.

Conditions studied

Coronary Artery Disease

Browse trials for

Coronary Artery Disease 5,598

Keywords

Atherosclerosis

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 2,509 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

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

Who can participate

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

Eligibility criteria

DAPT Group - Inclusion Criteria:

Phase I: Enrollment Inclusion Criteria

Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:

The subject must be 18 years of age.
Subjects undergoing percutaneous intervention with stent deployment
Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
The subject or Legally Authorized Representative has consented to participate and has authorized the collection and release of his/her medical information by signing the "Patient Informed Consent Form" that is approved by the Institutional Review Board or Independent Ethics Committee. The informed consent will be valid for the duration of the trial or until the subject withdraws.

DAPT Group Phase II: Randomization Inclusion Criterion at 12 months

Subjects must meet the following criterion to be eligible for randomization in the study:

Subject is 12 Month Clear

DAPT Group - Exclusion Criteria:

Phase I: Enrollment Exclusion Criteria

Subjects will be excluded if ANY of the following exclusion criteria apply:

Index procedure requiring use of a stent with a nominal diameter \< 2.25 mm or > 3.5 mm.
Pregnant women.
Planned (at time of enrollment) 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 where the primary endpoint has not been reached or the device/drug might affect major endpoint outcomes in either Phase I or Phase II of the study.
The subject may only be enrolled in the 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.

DAPT Group Phase II: Randomization Exclusion Criteria at 12 months

Subjects will be excluded from randomization if any of the following criteria are met:

Pregnant women.
Subject switched thienopyridine type within 6 months prior to randomization
Percutaneous coronary interventions 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 subsequent warfarin or similar anticoagulant therapy.
Subjects who do not receive any CYPHER® Stent during the index procedure.

Non-DAPT Group

The following inclusion and exclusion criteria are for the Non-DAPT subjects. These criteria will be used to determine if the subject meets the near on-label definition

Non-DAPT Group - Inclusion Criteria:

Subjects must meet ALL of the following criteria to be enrolled in this study:

The subject must be ≥18 years of age
Index procedure requiring use of a stent with a nominal diameter 2.25mm to 3.5mm
Lesion Length ≤ 34mm
Up to 2 lesions in up to 2 vessels (2 in one vessel or 1 in each of 2 vessels)
Ejection fraction > 30%
Target lesion stenosis is >50% and \<100% (visual estimate)
Female of childbearing potential must have a negative pregnancy test within 10 days prior to enrollment
The subject or Legally Authorized Representative has consented to participate and has authorized the collection and release of his/her medical information by signing the "Patient Informed Consent Form"

Non-DAPT Group - Exclusion criteria

And must NOT meet any of the following exclusion criteria:

Target Lesion includes Bifurcations with side branch diameter >2.5mm
Patient with excessive calcified/angulated lesion that is not suitable for stenting in the Investigator's opinion
Restenotic Target Lesion previously treated with a stent
Greater than 2 overlapping stents used to treat target lesion.
Target Lesion within an unprotected Left Main (LM) with ≥50% stenosis
Target Lesion within a coronary bypass graft (e.g., saphenous vein or arterial graft)
Chronic (> 3 months) Total Occlusion (CTO) Lesions, TIMI grade 0 or 1 in the target lesion
ST segment Elevation Myocardial Infarction (STEMI) within 30 days or non-STEMI within 72 hours
Renal insufficiency (creatinine >2.5 mg) or dialysis dependent
Lesion with visible clot
Patient with prior brachytherapy
Documented left ventricular ejection fraction is ≤30%
Pretreatment with devices other than conventional balloon angioplasty
Recipient of heart transplant
Subject with a life expectancy less than 1 year
Known allergies to the following: aspirin, all commercially available anti-platelet drugs heparin, stainless steel, contrast agent (that cannot be managed medically), or sirolimus (that cannot be managed medically);
Any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study;
Currently participating in an investigational drug or device study that has either not completed the primary endpoint where the prior study drug/device might affect this study's primary endpoint
In the Investigator's opinion, the lesion is not suitable for stenting.
Known bleeding or hypercoagulable disorder;
Known or suspected active infection at the time of the study procedures;
Subject is known to be pregnant
Subject is a prisoner, mentally incompetent, and/or alcohol or drug abuser;
Planned (at the time of enrollment) surgery necessitating discontinuation of anti-platelet therapy within the twelve (12) months following enrollment.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 2,509 participants (actual)

Study arms

Placebo comparator
12m DAPT Group
Drug: Placebo & Aspirin
Active comparator
30m DAPT Group
Drug: Clopidogrel & Aspirin, Prasugrel & Aspirin

Interventions

DrugClopidogrel & Aspirin, Prasugrel & Aspirin
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 thienopyridine treatment in addition to aspirin.
DrugPlacebo & Aspirin
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.

What researchers measure

Primary outcomes

Phase I: the Rate of Target Lesion Failure (TLF)
Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.
Time frame: 12 months

Secondary outcomes

Rate of Device Success
A study device success is defined as achievement of a final residual diameter stenosis of \< 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
Time frame: From post- procedure to hospital discharge, up to 39 days
Rate of Lesion Success
Lesion success is defined as the attainment of \< 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.
Time frame: From post- procedure to hospital discharge, up to 39 days
Rate of Procedure Success
Procedure success is defined as the achievement of a final diameter stenosis of \< 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.
Time frame: From post- procedure to hospital discharge, up to 39 days
Rate of Clinically-driven Target Lesion Revascularization (TVR)
Defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.
Time frame: 12 Months
Rate of Clinically Driven Target Vessel Revascularization (TVR)
Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.
Time frame: 12 months
Rate of Target Vessel Failure (TVF)
Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
Time frame: 12 Months
Rate of Major Adverse Cardiac Events (MACE)
MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months
Time frame: 12 Months
Rate of Protocol Defined Stent Thrombosis (ST)
Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring \> 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.
Time frame: 12 Months
Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)
ARC defined ST classifies ST by type - definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death \> 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those \> 24 hours to ≤ 30 days post procedure; and late includes those \> 30 days to ≤ 1 year post procedure; and very late includes those \> 1 year post procedure.
Time frame: 12 Months
Rate of Protocol Defined Major Bleeding Complications
Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.
Time frame: 12 Months
Rate of Cardiac Death
Include all deaths due to cardiac causes.
Time frame: 12 Months
Rate of Non-cardiac Death
Include all deaths due to non-cardiac causes.
Time frame: 12 Months

Results

Posted Oct 9, 2013

Participant flow

A total of 2509 patients were enrolled from August 28, 2009 to January 14, 2011 across 139 clinical sites in the Unites States.

Participant flow — Overall Study
Milestone	All Enrolled Subjects
Started	2509
Completed	2342
Not completed	167
Withdrew: Death	34
Withdrew: Withdrawal by subject	100
Withdrew: Lost to follow-up	33

Outcome measures

PrimaryPhase I: the Rate of Target Lesion Failure (TLF)

Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.

Time frame:: 12 months
Reported as:: Number · participants

Phase I: the Rate of Target Lesion Failure (TLF)
participants	CYPHER® Stent
Phase I: the Rate of Target Lesion Failure (TLF)	149

Statistical analysis

CYPHER® Stent · Rate of tlf at 12-month (%): 6.4 · 95% CI 5.5 to 7.5

SecondaryRate of Device Success

A study device success is defined as achievement of a final residual diameter stenosis of \< 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.

Time frame:: From post- procedure to hospital discharge, up to 39 days
Reported as:: Number · Devices

Rate of Device Success
Devices	CYPHER® Stent
Rate of Device Success	3205

Statistical analysis

CYPHER® Stent · Rate of device success (%): 98.0 · 95% CI 97.4 to 98.4

SecondaryRate of Lesion Success

Lesion success is defined as the attainment of \< 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.

Time frame:: From post- procedure to hospital discharge, up to 39 days
Reported as:: Number · Lesions

Rate of Lesion Success
Lesions	CYPHER® Stent
Rate of Lesion Success	3264

Statistical analysis

CYPHER® Stent · Rate of lesion success (%): 99.8 · 95% CI 99.6 to 99.9

SecondaryRate of Procedure Success

Procedure success is defined as the achievement of a final diameter stenosis of \< 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.

Time frame:: From post- procedure to hospital discharge, up to 39 days
Reported as:: Number · participants

Rate of Procedure Success
participants	CYPHER® Stent
Rate of Procedure Success	2444

Statistical analysis

CYPHER® Stent · Rate of procedure success (%): 97.7 · 95% CI 97.0 to 98.2

SecondaryRate of Clinically-driven Target Lesion Revascularization (TVR)

Defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Clinically-driven Target Lesion Revascularization (TVR)
participants	CYPHER® Stent
Rate of Clinically-driven Target Lesion Revascularization (TVR)	98

Statistical analysis

CYPHER® Stent · Rate of clinically-driven tlr (%): 4.2 · 95% CI 3.45 to 5.13

SecondaryRate of Clinically Driven Target Vessel Revascularization (TVR)

Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.

Time frame:: 12 months
Reported as:: Number · participants

Rate of Clinically Driven Target Vessel Revascularization (TVR)
participants	CYPHER® Stent
Rate of Clinically Driven Target Vessel Revascularization (TVR)	124

Statistical analysis

CYPHER® Stent · Rate of clinically-driven tvr (%): 5.8 · 95% CI 4.87 to 6.81

SecondaryRate of Target Vessel Failure (TVF)

Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Target Vessel Failure (TVF)
participants	CYPHER® Stent
Rate of Target Vessel Failure (TVF)	184

Statistical analysis

CYPHER® Stent · Rate of target vessel failure (%): 7.92 · 95% CI 6.85 to 9.09

SecondaryRate of Major Adverse Cardiac Events (MACE)

MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Major Adverse Cardiac Events (MACE)
participants	CYPHER® Stent
Rate of Major Adverse Cardiac Events (MACE)	172

Statistical analysis

CYPHER® Stent · Rate of mace (%): 7.41 · 95% CI 6.37 to 8.55

SecondaryRate of Protocol Defined Stent Thrombosis (ST)

Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring \> 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Protocol Defined Stent Thrombosis (ST)
participants	CYPHER® Stent
Rate of Protocol Defined Stent Thrombosis (ST)	21

Statistical analysis

CYPHER® Stent · Rate of protocol defined st (%): 0.91 · 95% CI 0.56 to 1.38

SecondaryRate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)

ARC defined ST classifies ST by type - definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death \> 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those \> 24 hours to ≤ 30 days post procedure; and late includes those \> 30 days to ≤ 1 year post procedure; and very late includes those \> 1 year post procedure.

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)
participants	CYPHER® Stent
Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)	26

Statistical analysis

CYPHER® Stent · Rate of arc defined st (%): 1.12 · 95% CI 0.74 to 1.64

SecondaryRate of Protocol Defined Major Bleeding Complications

Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Protocol Defined Major Bleeding Complications
participants	CYPHER® Stent
Rate of Protocol Defined Major Bleeding Complications	71

Statistical analysis

CYPHER® Stent · Rate of major bleeding complications (%): 3.07 · 95% CI 2.40 to 3.85

SecondaryRate of Cardiac Death

Include all deaths due to cardiac causes.

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Cardiac Death
participants	CYPHER® Stent
Rate of Cardiac Death	18

Statistical analysis

CYPHER® Stent · Rate of cardiac death (%): 0.78 · 95% CI 0.46 to 1.23

SecondaryRate of Non-cardiac Death

Include all deaths due to non-cardiac causes.

Time frame:: 12 Months
Reported as:: Number · participants

Rate of Non-cardiac Death
participants	CYPHER® Stent
Rate of Non-cardiac Death	16

Statistical analysis

CYPHER® Stent · Rate of non-cardiac death (%): 0.69 · 95% CI 0.40 to 1.12

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CYPHER® Stent	—	34/2,509 (1.4%)	414/2,509 (16.5%)

Most frequent serious events

Most frequent serious events
Event	CYPHER® Stent
Cardiac DeathCardiac disorders	18/2509
Non-cardiac deathGeneral disorders	16/2509

Most frequent other events

Most frequent other events
Event	CYPHER® Stent
Angina pectorisCardiac disorders	108/2509
Coronary artery dissectionCardiac disorders	79/2509
Myocardial infarctionCardiac disorders	76/2509
Angina unstableCardiac disorders	53/2509
Coronary artery diseaseCardiac disorders	43/2509
Catheter site haematomaGeneral disorders	39/2509
Coronary artery occlusionCardiac disorders	31/2509
In-stent coronary artery restenosisInjury, poisoning and procedural complications	28/2509
EpistaxisRespiratory, thoracic and mediastinal disorders	27/2509
Cardiac enzymes increasedInvestigations	26/2509

Baseline characteristics

Enrolled subjects were those who signed the informed consent and had met all of the inclusion and none of the exclusion criteria, and the target lesion had been successfully crossed with the intracoronary guidewire which was positioned intraluminally in the distal vessel. Enrolled subjects were also Intent to Treat (ITT).

Age, Categorical
Age, Categorical(Participants)	CYPHER® Stent
<=18 years	0
Between 18 and 65 years	1368
>=65 years	1141

Age, Continuous
Age, Continuous(years)	CYPHER® Stent
Mean	63.26 ± 10.64

Sex: Female, Male
Sex: Female, Male(Participants)	CYPHER® Stent
Female	785
Male	1724

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	CYPHER® Stent
Hispanic or Latino	132
Not Hispanic or Latino	2293
Unknown or Not Reported	84

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CYPHER® Stent
American Indian or Alaska Native	6
Asian	37
Native Hawaiian or Other Pacific Islander	6
Black or African American	185
White	2225
More than one race	0
Unknown or Not Reported	50

Region of Enrollment
Region of Enrollment(participants)	CYPHER® Stent
United States	2509

Study locations

1 site

University Hospitals, Case Medical Center (Cleveland)
Cleveland, Ohio 44106, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00954707
Lead sponsor: Cordis Corporation
Responsible party: Sponsor
First posted: Aug 7, 2009
Start date: Aug 2009
Primary completion: Jan 2012
Completion: Mar 2016 (estimated)
Results posted: Oct 9, 2013
Last update: Feb 7, 2014

Study contacts

Daniel Simon, M.D.

principal investigator · University Hospitals, Case Medical Center (Cleveland)

David Kandzari, M.D.

principal investigator · Piedmont Hospital, Atlanta, GA

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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