Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of aspirin-free, P2Y12 inhibitor single antiplatelet and colchicine treatment in patients with acute coronary syndrome treated with drug-eluting stents.
详细描述
After successful drug-eluting stent implantation for acute coronary syndrome, screening for study subject enrollment is performed. For those who submitted written informed consent, aspirin is stopped the day after the intervention, and colchicine 0.6mg once daily is started. The P2Y12 inhibitor, prasugrel or ticagrelor, for single antiplatelet therapy remains. For the duration of hospital stay, platelet reactivity using VerifyNow test and C-reactive protein are measured. Aspirin may be restarted at the discretion of the investigator based on results of the platelet function test. C-reactive protein is remeasured 30 days after the intervention. Clinical follow-up is performed 30 days and 90 days after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful PCI with drug-eluting stent for NSTE-ACS or STEMI
- •Provision of written informed consent
排除标准
- •Cardiac arrest or cardiogenic shock
- •Age <19 or >90 years old
- •Severe liver impairment
- •Severe renal impairment (eGFR <30 mL/min/1.73 m2)
- •Atrial fibrillation requiring anticoagulation therapy
- •Intolerance of prasugrel, ticagrelor, or colchicine
- •History of intracranial hemorrhage
- •Active bleeding
研究组 & 干预措施
Mono Antiplatelet and Colchicine Therapy
Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment
干预措施: Aspirin (Drug)
Mono Antiplatelet and Colchicine Therapy
Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment
干预措施: Colchicine (Drug)
结局指标
主要结局
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
时间窗: Assessed at hospital stay and 30/90 days after stent implantation
Definite, probable, and possible stent thrombosis (Academic Research Consortium)
次要结局
- Clinical outcomes - TV-MI and non-TV-MI(Assessed at hospital stay and 30/90 days after stent implantation)
- Clinical outcomes - All revascularization(Assessed at hospital stay and 30/90 days after stent implantation)
- Clinical outcomes - Target vessel failure(Assessed at hospital stay and 30/90 days after stent implantation)
- Laboratory outcomes - P2Y12 reaction unit(Assessed at hospital stay)
- Laboratory outcomes - Percent platelet inhibition(Assessed at hospital stay)
- Laboratory outcomes - C-reactive protein(Assessed at hospital stay and 30 days after stent implantation)
- Clinical outcomes - Target lesion failure(Assessed at hospital stay and 30/90 days after stent implantation)
- Clinical outcomes - All-cause mortality(Assessed at hospital stay and 30/90 days after stent implantation)
- Clinical outcomes - Cardiac and non-cardiac mortality(Assessed at hospital stay and 30/90 days after stent implantation)
- Clinical outcomes - All myocardial infarction(Assessed at hospital stay and 30/90 days after stent implantation)
- Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR(Assessed at hospital stay and 30/90 days after stent implantation)
- Clinical outcomes - Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)(Assessed at hospital stay and 30/90 days after stent implantation)
研究者
Seung-Yul Lee
Associate Professor
Wonkwang University Hospital