NCT01349777已完成4 期
Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)
Seung-Jung Park3 个研究点 分布在 1 个国家目标入组 1,056 人开始时间: 2010年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,056
- 试验地点
- 3
- 主要终点
- composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
研究概览
简要总结
This study is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in patients undergoing PCI compared to conventional clopidogrel (Plavix®).
详细描述
Prospective, two arms, randomized multi-center trial of 1,056 patients enrolled at 3 centers in Korea.
Following angiography, patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Pregrel® group vs. b) Plavix®. This trial is the non-inferiority study to demonstrate that the incidence of 12 months primary end-point in Pregrel® group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •The patient must be at least 18 years of age.
- •Patients with symptomatic coronary artery disease with objective evidence of ischemia (e.g. symptoms of angina pectoris, positive stress test results, or dynamic ECG changes).
- •Patients are referred for PCI, or thought to be at high likelihood for requiring stent placement with or without conventional balloon angioplasty
- •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications:
- •Both Clopidogrel and Ticlopidine
- •Stainless steel and/or
- •Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenylhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- •Coronary anatomy not amenable to stent placement
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- •An elective major surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Administration of the following medications prior to randomization: GpIIb-IIIa inhibitor and clopidogrel within 7 days (already received pretreatment), or thrombolytics within 24 hours.
- •Long-term (at least > 3 months) use or requirement of NSAID or anticoagulation
- •Patients with cardiogenic shock
- •Acute MI patients within symptom onset < 12 hours needing primary angioplasty
- •Patients with left main stem stenosis (>50% by visual estimate)
研究组 & 干预措施
Pregrel®
Experimental
clopidogrel
干预措施: Pregrel® (Drug)
Plavix®
Active Comparator
clopidogrel
干预措施: Plavix® (Drug)
结局指标
主要结局
composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
时间窗: 12 months
次要结局
- composite of death, MI, stroke, or urgent revascularization(6 months)
- Individual components of death, MI, stroke, or urgent revascularization(12 months)
- The incidence of early discontinuation of study drugs(12 months)
- The incidence of major bleeding events(12 months)
- The need for target vessel revascularization or any revascularization(12 months)
- Stent thrombosis(12 months)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
研究点 (3)
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