Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,226
- 试验地点
- 1
- 主要终点
- Composite primary outcome measure consisting of Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization.
研究概览
简要总结
This study evaluates the efficacy of Prasugrel and Ticagrelor in the treatment of acute myocardial infarction.
详细描述
Study objectives:
- Compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with emergent PCI.
- Assess the safety of switching to clopidogrel after remission of the acute phase of MI in patients for whom economic barriers do not allow to continue treatment with prasugrel or ticagrelor. All randomized patients with acute myocardial infarction have been treated with standard therapeutic procedures in accordance with the guidelines of European Society of Cardiology (ESC). Participation of patients in the study is not connected to any deviations from the ESC guidelines recommendations.
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
- Single (Outcomes Assessor)
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
- •Acute myocardial infarction (> 1mm ST elevation in at least 2 related leads or ST depression > 2mm in 3 leads or new BBB) with an indication to emergent (within 120 minut from admission to the PCI center) coronary angiography and PCI,
- •Signed informed consent.
排除标准
- •History of stroke,
- •Serious bleeding within last 6 months,
- •Indication to an oral anticoagulation (e.g. atrial fibrillation, artificial valve, thromboembolism etc...)
- •Use of ≥ 300 mg of clopidogrel or another antiplatelet agent (except of aspirin and lower dose of clopidogrel) before randomization,
- •Low body weight (<60 kg) in an older patient (>75 years of age),
- •Moderate or severe liver dysfunction,
- •Ongoing therapy with a strong CYP3A4 inhibitor (e.g. ketoconazole, clarythromycine, nefazodone, ritonavir, atazanavit),
- •Hypersensitivity to prasugrel or ticagrelor.
研究组 & 干预措施
Patients treated with Prasugrel
Prasugrel Loading dose: 60 mg Maintenance dose: 10 mg once-daily; patients >75 years of age or < 60 kg of weight receive a maintenance dose of 5 mg o.d.
干预措施: Prasugrel (Drug)
Patients treated with ticagrelor
Ticagrelor Loading dose: 180 mg Maintenance dose: 90mg twice-daily
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Composite primary outcome measure consisting of Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization.
时间窗: Within 7 days after Randomization.
Definitions: Death defined as summary of death from any cause. Re-infarcion defined according to the Third Universal Definition of Myocardial Infarction. Stroke defined as the rapid onset of new neurological deficit caused by an ischemic or hemorrhagic central nervous system event with symptoms that lasted at least 24 hours after onset or leading to death. Urgent Target Vessel Revascularization defined as a new emergent/urgent revascularization of the vessel dilated at the initial procedure driven by recurrent signs of ischemia occurring after completion of initial PCI. Units: The percentage of randomized patients is the total number of randomized patients experiencing Death / Re-infarction / Stroke / Serious bleeding requiring transfusion or prolonged hospitalization / Urgent Target Vessel Revascularization divided by number of randomized patients in the treatment arm multiplied by 100. Primary endpoint is adjudicated by the Independent Control committee
次要结局
- Occurence of bleeding according to the TIMI and BARC criteria.(Within 30 days and one year after Randomization.)
- Composite secondary outcome measure consisting of Cadiovascular death / Non-fatal myocardial infarction / Stroke.(Within 30 days and one year after Randomization.)
- Stent thrombosis.(Within 30 days and one year after Randomization.)
研究者
Zuzana Motovska
Accociate Professor
Faculty Hospital Kralovske Vinohrady