Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Intramyocardial haemorrhage (IMH)
研究概览
简要总结
The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and electrocardiographical diagnosis of STEMI
- •Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)
排除标准
- •Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
- •Previous PCI or MI less than 12 months ago
- •Previous cardiac surgery
- •Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))
- •Pregnancy and breast feeding
- •Concurrent use of oral anticoagulants (OAC)
- •The periprocedural use of GPIIb/IIIa inhibitors
- •Planned surgical intervention within 12 months of PCI
- •Creatinine clearance <30mL/min or dialysis
- •PCI of stent thrombosis
- •Suboptimal stent result as judged by the interventional cardiologist.
- •Life expectancy shorter than 13 months.
- •Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).
研究组 & 干预措施
Treatment arm
Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)
干预措施: Ticagrelor (Drug)
Control arm
Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.
干预措施: Ticagrelor (Drug)
Control arm
Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.
干预措施: Aspirin (Drug)
结局指标
主要结局
Intramyocardial haemorrhage (IMH)
时间窗: day 5-8 post primary PCI
Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post primary PCI.
Composite of major adverse cardiac and cerebral events (MACCE)
时间窗: 3 and 13 months after primary PCI
Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality
次要结局
- Bleeding complications(3 and 13 months after primary PCI)
- All-cause mortality(3 and 13 months after primary PCI)
- Platelet reactivity(5-8 days)