Phase III, Randomized, International, Multicenter, Open Label, With Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With Acute Coronary Syndrome With ST Elevation Treated With Pharmacological Thrombolysis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,799
- 试验地点
- 153
- 主要终点
- Safety Outcome as a measure of Time to TIMI-defined first major bleeding
研究概览
简要总结
Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with pharmacological thrombolysis
详细描述
Phase III, Randomized, International, Multicenter, Open label, with Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome with ST Elevation Treated with Pharmacological Thrombolysis.
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
Blinded adjudication
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
- •Patients of both sexes aged ≥ 18 years and < 75 years with ACS with ST segment elevation with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of > 10 minutes duration at rest, treated with pharmacological thrombolysis
- •Fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours
- •Patients with acute coronary syndrome with ST segment elevation will be included provided they present ST segment elevation at the J point in two contiguous leads in electrocardiogram with cut-points: > 0.1mV in all leads other than leads V2-V3, where the following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or >0.15 mV in women and at least 1 of the following criteria:
- •Angina-like chest pain or ischemic equivalent chest pain;
- •Abnormalities above the reference value for markers of myocardial necrosis (troponin and CK-MB).
- •The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
排除标准
- •Any contraindication against the use of clopidogrel (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, history of intracranial hemorrhage)
- •Need for oral anticoagulation therapy,
- •Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3Ainducers (rifampin/rifampicin, phenytoin, carbamazepine)
- •Increased risk of bradycardia events
- •Dialysis required
- •Known clinically important thrombocytopenia
- •Known clinically important anemia
- •Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer)
- •Participant in another investigational drug or device study within 30 d
- •Pregnancy or lactation
- •Any condition that increases the risk for noncompliance or being lost to follow-up
- •Involvement in the planning or conduct of the study
- •Previous enrollment or randomization in this study
- •Contraindications to fibrinolytic therapy including: 15
- •Any prior intracranial hemorrhage
- •Known structural cerebral vascular lesion (eg, Arterial Venous Malformation - AVM)
- •Known malignant intracranial neoplasm (primary or metastatic)
- •Ischemic stroke within 3 months
- •Suspected aortic dissection
- •Active bleeding or bleeding diathesis (excluding menses)
- •Significant closed head trauma or facial trauma within 3 months
研究组 & 干预措施
Ticagrelor 180 mg
Patients assigned to Ticagrelor will receive oral Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.
干预措施: Ticagrelor 180 mg (Drug)
Clopidogrel
Patients will take the 300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months.
For patients with > 75 years the recommended load dose is 75 mg instead 300 mg.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Safety Outcome as a measure of Time to TIMI-defined first major bleeding
时间窗: 30 days
The primary safety endpoint is time to TIMI-defined and adjudicated first major bleeding event (including major life-threatening bleeding and other major bleeding). Bleeding TIMI Definition Major: Any intracranial hemorrhage (ICH)\*, OR Clinically significant overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of ≥ 5 g/dL (or, when Hgb is not available, an absolute drop in hematocrit (Hct) of ≥ 15%). An independent blinded central adjudication committee will adjudicate all suspected primary end points.
次要结局
- Efficacy Outcome as a measure of major cardiovascular events(12 months)
- Safety Outcome as a measure of bleeding event(12 months)