The 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
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Composite of major adverse cardiac and cerebral events (MACCE), consisting of: Myocardial infarction; Stent thrombosis; Ischemic stroke;Cardiovascular mortality.
研究概览
简要总结
To assess whether direct omission of aspirin after primary 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 STEMI patients. Furthermore, the two treatment strategies will be compared regarding the incidence and extent of IMH in the first week after PCI
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 DES
排除标准
- •Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
- •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)
- •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 <30 mL/min or dialysis
结局指标
主要结局
Composite of major adverse cardiac and cerebral events (MACCE), consisting of: Myocardial infarction; Stent thrombosis; Ischemic stroke;Cardiovascular mortality.
Composite of major adverse cardiac and cerebral events (MACCE), consisting of: Myocardial infarction; Stent thrombosis; Ischemic stroke;Cardiovascular mortality.
Infarct size and size of IMH determined by CMR at day 5-8 post-PPCI.
Infarct size and size of IMH determined by CMR at day 5-8 post-PPCI.
次要结局
- Bleeding complications BARC ≥ 2
- All-cause mortality
- To compare platelet reactivity between ticagrelor monotherapy and ticagrelor + ASA.
- To assess the anti-inflammatory effects of ticagrelor with or without aspirin on the inflammation response elicited by the myocardial infarction.
- To assess coagulation factors after the myocardial infarction in patients using ticagrelor with or without aspirin.
研究者
Peter Damman
Scientific
Radboud universitair medisch centrum Stichting