NCT02939872已完成4 期
Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial
Seung-Jung Park2 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2017年3月9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
- 238
- 试验地点
- 2
- 主要终点
- composite event of death, myocardial infarction, or stroke
研究概览
简要总结
The purpose of this study is to evaluate optimal duration of antiplatelet therapy after Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic events.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 19 years of age
- •Patients undergoing dual- or triple-antiplatelet therapy at least 12-14 months after PCI with BVS
- •Among the participants underwent PCI with BVS, event-free patients who survived the first 12 months without death, serious MI, stroke, repeat revascularization or major bleeding (except non-significant peri-procedural MI)
- •The patient or guardian agrees to the study protocol and the schedule of clinical 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
- •Contraindication to antiplatelet therapy
- •If the physician believes that the patient need continuation of dual anti-platelet therapy because of comorbidities (ACS, peripheral vascular disease, significant carotid disease, etc.)
- •Continuous administration of clopidogrel is impossible due to comorbidities of the patient (major bleeding history, bleeding diathesis)
- •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).
- •Pregnancy test positive (hCG test is performed before randomization in all fertile women)
研究组 & 干预措施
DAPT
Experimental
Dual antiplatelet therapy : aspirin and clopidogrel
干预措施: aspirin and clopidogrel (Drug)
Clopidogrel only
Active Comparator
Clopidogrel monotherapy
干预措施: Clopidogrel only (Drug)
结局指标
主要结局
composite event of death, myocardial infarction, or stroke
时间窗: 1 year
次要结局
- Target Lesion Revascularization(5 years)
- Stent thrombosis(5 years)
- Bleeding(5 years)
- Death(5 years)
- Myocardial Infarction(5 years)
- Stroke(5 years)
- Target Vessel Revascularization(5 years)
研究者
Seung-Jung Park
professor, Division of Cardiology, Department of Internal Medicine
Asan Medical Center
研究点 (2)
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