EUCTR2007-006263-68-AT进行中（未招募）1 期
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF 6 MONTHS VERSUS 12 MONTHS CLOPIDOGREL THERAPY AFTER IMPLANTATION OF A DRUG-ELUTING STENT SAFETY AND EFFICACY OF SIX MONTHS DUAL ANTIPLATELET THERAPY AFTER DRUG-ELUTING STENTING – ISAR-SAFE - ISAR-SAFE
Deutsches Herzzentrum Muenchen0 个研究点目标入组 6,000 人开始时间: 2010年6月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
- •2.Informed, written consent by the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Age =18 years
- •2.Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
- •3.Previous stent thrombosis
- •4.DES in left main coronary artery
- •5.STEMI and NSTEMI during the last 6 months
- •6.Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
- •7.Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
- •8.Active bleeding; bleeding diathesis; history intracranial bleeding
- •9.Oral anticoagulation therapy with coumadin derivatives
- •10.Known allergy or intolerance to the study medications: aspirin and clopidogrel
- •11. Pregnancy (present, suspected or planned) or positive pregnancy test
- •(In women with childbearing potential a negative pregnancy test is mandatory.)
- •12.Patient’s inability to fully comply with the study protocol
- •13.Prior enrollment in the same clinical trial
研究者
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