TIPRIS: Ticagrelor vs. Prasugrel Effects on Infarct Size: A Head to Head Comparison With Prasugrel
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Efficacy as measured by infarct size on all randomized patients.
研究概览
简要总结
This study has been designed as a randomized, double-blind trial to provide definitive evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with anterior ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary Percutaneous Coronary Intervention (PCI). This study will also measure the effects of ticagrelor vs. prasugrel on secondary endpoints listed above. This study design aims to test the hypothesis that ticagrelor will reduce myocardial infarct size as a proportion of the ischemic area at risk when compared to prasugrel.
详细描述
Subjects and research staff (including the Magnetic Resonance Imaging (MRI) readers and interventional cardiologists) will not know what active treatment study drug the subjects are receiving.
Study Arm 1: Ticagrelor (180 mg loading dose, followed by 90 mg twice a day) PO plus matching placebo
Study Arm 2: Prasugrel (60 mg loading dose followed by 5 or 10 mg once per day based on weight) PO plus matching placebo
Additional study drug: Aspirin (81mg per day)
Participation in this study will be about 90 days and includes 4 study visits (other than your hospital stay) and 3 telephone calls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Informed consent: Signed informed consent prior to any study specific procedures
- •Age: Male and females aged 18 years and older
- •Onset: Presenting to emergency room or cardiac catheterization laboratory within 6 hours of onset of myocardial infarction symptoms
- •Continuing to have ongoing myocardial infarction symptoms
- •EKG findings: ST elevation on ECG with positive T waves in the precordial leads, suggestive of anterior STEMI
- •Triaged for emergency cardiac catheterization (primary PCI protocol)
- •Agree to use an effective contraceptive method beginning at the signing of the informed consent and for at least 30 days after the last dose of study drug. The definition of an effective method of contraception will be based on the judgment of the investigator.
排除标准
- •Prior myocardial infarction
- •Contraindication to ticagrelor and/or prasugrel
- •Contraindication to gadolinium
- •Contraindication to aspirin
- •Treatment with fibrinolytic therapy for the index STEMI
- •High risk of bleeding
- •Presenting with cardiogenic shock
- •Infarction due to stent thrombosis
- •History of a previous coronary artery bypass graft (CABG)
- •Known renal insufficiency (acute kidney injury or Glomerular Filtration Rate < 40 mL/min/1.73 m2).
- •Moderate or severe hepatic impairment
- •Inability to undergo cardiac MRI
- •Indication for aspirin >162 mg/d
- •Indication for Nonsteroidal Anti-Inflammatory Drugs or COX2 inhibitors
- •Breast feeding
- •History of intracranial hemorrhage
研究组 & 干预措施
ticagrelor or matching placebo
ticagrelor (180 mg loading followed by 90 mg twice daily) or matching placebo
干预措施: ticagrelor (Drug)
ticagrelor or matching placebo
ticagrelor (180 mg loading followed by 90 mg twice daily) or matching placebo
干预措施: Placebo (Drug)
prasugrel or matching placebo
prasugrel (60 mg loading followed by 5-10 mg/d) or matching placebo
干预措施: prasugrel (Drug)
prasugrel or matching placebo
prasugrel (60 mg loading followed by 5-10 mg/d) or matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy as measured by infarct size on all randomized patients.
时间窗: up to Day 90
次要结局
- Safety as measured by incidences of treatment emergent adverse events, serious adverse events, treatment-related adverse events and adverse events leading to stop of drug(90 days)
研究者
Yochai Birnbaum
Professor
Baylor College of Medicine