EUCTR2009-015712-17-FR进行中（未招募）1 期
A prospective, multi-center, randomized, double-blind trial to assess theeffectiveness and safety of 12 versus 30 months of dual antiplatelet therapy(DAPT) in subjects undergoing percutaneous coronary intervention (PCI) witheither drug-eluting stent (DES) or bare metal stent (BMS) placement for thetreatment of coronary artery lesions. - DAPT Study
HCRI0 个研究点目标入组 20,645 人开始时间: 2010年2月2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
- 20,645
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
- •Enrollment inclusion criteria:
- •Subject must meet all of the following criteria to be eligible for treatment in the study:
- •1. Subject is > 18 years of age.
- •2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
- •3. Subjects without known contraindication to dual antiplatelet therapy for at least
- •30 months after enrollment and stent implantation.
- •4. The subject has consented to participate and has authorized the collection and
- •release of his medical information by signing the Patient Informed Consent
- •Form”. The informed consent will be valid for the duration of the trial or until the
- •subject withdraws.
- •Randomisation inclusion criteria:
- •Subject is 12 Month Clear”. Defined as subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding –severe” or moderate” by GUSTO classification, and ST 12 months after stent implantation and who are compliant with 12 months of DAPT following stent implantation.
- •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
- •Enrollment exclusion criteria:
- •1. Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm.
- •2. Pregnant women.
- •3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30
- •months following enrollment.
- •4. Current medical condition with a life expectancy of less than 3 years.
- •5. Concurrent enrollment in another device or drug study whose protocol
- •specifically excludes concurrent enrollment or that involves blinded placement of
- •a DES or BMS other than those included as DAPT study devices. The subject
- •may only be enrolled in the DAPT Study once.
- •6. Subjects on warfarin or similar anticoagulant therapy.
- •7. Subjects with hypersensitivity or allergies to one of the drugs or components
- •indicated in the Instructions for Use for the device implanted.
- •8. Subjects unable to give informed consent.
- •9. Subject treated with both DES and BMS during the index procedure.
- •Randomisation exclusion criteria:
- •1. Pregnant women.
- •2. Subject switched thienopyridine type or dose within 6 months prior to
- •randomization.
- •NOTE: thienopyridine switching during the open label portion of this study is
- •discouraged.
- •3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post
- •index procedure and randomization.
- •4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21
- •months following randomization.
- •5. Current medical condition with a life expectancy of less than 3 years.
- •6. Subjects on warfarin or similar anticoagulant therapy.
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