NCT00954707Unknown4 期
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)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 2,509
- 试验地点
- 1
- 主要终点
- Phase I: the Rate of Target Lesion Failure (TLF)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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
- 另有 9 项未显示
研究组 & 干预措施
12m DAPT Group
Placebo Comparator
干预措施: Placebo & Aspirin (Drug)
30m DAPT Group
Active Comparator
干预措施: Clopidogrel & Aspirin, Prasugrel & Aspirin (Drug)
结局指标
主要结局
Phase I: the Rate of Target Lesion Failure (TLF)
时间窗: 12 months
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.
次要结局
- Rate of Device Success(From post- procedure to hospital discharge, up to 39 days)
- Rate of Lesion Success(From post- procedure to hospital discharge, up to 39 days)
- Rate of Procedure Success(From post- procedure to hospital discharge, up to 39 days)
- Rate of Clinically-driven Target Lesion Revascularization (TVR)(12 Months)
- Rate of Clinically Driven Target Vessel Revascularization (TVR)(12 months)
- Rate of Target Vessel Failure (TVF)(12 Months)
- Rate of Major Adverse Cardiac Events (MACE)(12 Months)
- Rate of Protocol Defined Stent Thrombosis (ST)(12 Months)
- Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)(12 Months)
- Rate of Protocol Defined Major Bleeding Complications(12 Months)
- Rate of Cardiac Death(12 Months)
- Rate of Non-cardiac Death(12 Months)
研究者
研究点 (1)
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