NCT02494284终止4 期
Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial
CHEOL WHAN LEE, M.D., Ph.D12 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2015年12月22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
- 终止
- 发起方
- 入组人数
- 364
- 试验地点
- 12
- 主要终点
- Number of participants with clinically relevant bleeding
研究概览
简要总结
The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.
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 with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents
- •Patients without major bleeding or MACE (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement
- •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
- •Persistent thrombocytopenia (platelet count <100,000/µl)
- •A known intolerance to a study drug (aspirin, clopidogrel)
- •Patients requiring long-term oral anticoagulants or cilostazol
- •Patients presented with acute myocardial infarction (STEMI or NSTEMI) at the time of index procedure
- •Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure
- •Bare-metal stent implantation at the time of index procedure
- •Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- •A diagnosis of cancer in the past 2 years or current treatment for the active cancer.
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- •History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
- •Unwillingness or inability to comply with the procedures described in this protocol.
- •Patients pregnant or breast-feeding or child-bearing potential.
研究组 & 干预措施
Short term dual therapy
Experimental
干预措施: Clopidogrel (Drug)
Long term dual therapy
Active Comparator
干预措施: Aspirin plus clopidogrel (Drug)
结局指标
主要结局
Number of participants with clinically relevant bleeding
时间窗: 18 months
clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure)
次要结局
- Number of participants with stent thrombosis(18 months)
- Number of participants with repeat revascularization(18 months)
- Number of participants with death from cardiovascular cause(18 months)
- Number of participants with myocardial infarction(18 months)
- Number of participants with stroke(18 months)
- Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5(18 months)
- Number of participants with a composite of death from vascular causes or myocardial infarction(18 months)
- Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)(18 months)
- Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis(18 months)
- Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5(18 months)
- Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.(18 months)
研究者
CHEOL WHAN LEE, M.D., Ph.D
M.D., Ph,D
Asan Medical Center
研究点 (12)
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