Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD): A Prospective, Multicenter, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,250
- 试验地点
- 97
- 主要终点
- Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke).
研究概览
简要总结
This study is a prospective, multicenter, parallel, open-label, randomized, controlled, superiority trial. It is planned to recruit 8,250 patients with multi-vessel disease(MVD), and the patients will be followed-up for at least 12 months after being implanted with a drug-eluting stent (DES) at one of 100 different centers. All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a permuted completely randomization.
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
盲法说明
This is an open-label trial, and the investigators and subjects will not be blinded. Under these conditions, the following methods will be employed to minimize bias:
- Clinical Endpoint Committee (CEC) is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical safety or efficacy events of interest;
- The statisticians are independent and blind to the grouping information.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The enrolled subjects must meet all of the following criteria:
- •Aged 18-75 years old (inclusive).
- •Patients with MVD who underwent DES implantation for 12 months.
- •Patients have been treated with aspirin and can tolerant of aspirin at doses of 75-150 mg/day as maintenance therapy during the study period.
- •Patients have signed informed consent.
排除标准
- •- Subjects who meet any one of the following criteria are excluded from the study:
- •Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol.
- •Contraindication to ADP receptor blockers or aspirin.
- •Planned to use anticoagulants during the study period.
- •Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period.
- •Planned major cardiac or non-cardiac surgery during the study period.
- •Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors.
- •Known severe liver disease(ALT/AST is 3 times above normal).
- •Subjects with renal failure who required or anticipated dialysis during the study period.
- •Platelet count <50×10^9/L.
- •Patients with:
- •A history of intracranial bleed or ischemic stroke at any time.
- •A central nervous system tumor or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time.
- •Intracranial or spinal cord surgery within 5 years.
- •Pregnancy or lactation or planned to pregnant during the study period.
- •Life expectancy < 1 year.
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer).
- •Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse).
- •Participation in another clinical study and did not reach the major endpoint.
- •Involvement in the planning and/or conduct of the study.
研究组 & 干预措施
Aspirin monotherapy
Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.
干预措施: Aspirin monotherapy (Drug)
Clopidogrel and aspirin dual-antiplatelet therapy
Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
干预措施: Clopidogrel and aspirin dual-antiplatelet therapy (Drug)
结局指标
主要结局
Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke).
时间窗: Through study completion, median follow-up duration is 34.3 months.
To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of MACCE in patients with MVD.
次要结局
- Incidence of all-cause mortality.(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of cardiovascular death.(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of nonfatal myocardial infarction.(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of nonfatal stroke.(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of NACE (net adverse clinical events).(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of cardiovascular death or hospitalization.(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of emergency revascularization.(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of repeat revascularization.(Through study completion, median follow-up duration is 34.3 months.)
- Incidence of definite/possible stent thrombosis.(Through study completion, median follow-up duration is 34.3 months.)
研究者
Yu Bo
Director
Harbin Medical University