Platelet Inhibition to Target Reperfusion Injury: The PITRI Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 228
- 试验地点
- 5
- 主要终点
- Myocardial infarct size by CMR at Day 2 to 7
研究概览
简要总结
There remains a clinical need to improve health outcomes in patients with ischemic heart disease (IHD) the leading cause of death and disability in Singapore and worldwide. One neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). This results in microvascular obstruction (MVO) and cardiomyocyte death and contributes upto 50% of the final myocardial infarct (MI) size. Cangrelor, a potent intravenous platelet P2Y12 inhibitor with rapid onset and offset of action, has been demonstrated in experimental animal studies to reduce MI size when administered prior to reperfusion. Whether Cangrelor given together with Ticagrelor would be more effective at reducing MI size in STEMI patients treated by PPCI is not known and is investigated in the Platelet Inhibition to Target Reperfusion Injury (PITRI) trial.
详细描述
The PITRI proof-of-concept clinical trial will randomise 210 STEMI patients to receive either Cangrelor (single intravenous bolus followed by a 120-minute infusion) or matching normal/saline placebo, initiated prior to PPCI on top of conventional oral dual antiplatelet therapy (Aspirin + Ticagrelor).
The primary endpoint will be acute MI size by cardiac MRI at day 2-7. Secondary endpoints will include incidence and extent of MVO by cardiac MRI; and chronic MI size, left ventricular size and ejection fraction by cardiac MRI at 6 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cangrelor
Cangrelor (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
干预措施: Cangrelor (Drug)
Placebo
Matching normal saline placebo (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
干预措施: Cangrelor (Drug)
结局指标
主要结局
Myocardial infarct size by CMR at Day 2 to 7
时间窗: 2-7 days
This will be measured by CMR (mass of late gadolinium enhancement expressed as a percentage of the LV mass).
次要结局
- Myocardial infarct size by CMR at 6 months(6 months)
- Post-MI LV remodeling by measuring LV ejection fraction and indexed LV end systolic and diastolic volumes and mass(6 months)
- Myocardial salvage index(2-7 days)
- Angiographic markers of successful reperfusion(2 to 3 hours)
- Microvascular obstruction to calculate myocardial interstitial volume(2-7 days)
- MACCE at 30 days, at 6 months, at 12 months, at 24 months, at 5 years and at 10 years(6 months)
- Subjective questionnaire(6 months)
- Platelet function testing(2 hours)
- Incidence of definite stent thrombosis at 48 hours(48 hours)
- Quality of life questionnaire(6 months)
- 6-Minute Walk Test (6MWT)(6 months)
- ALDH2 substudy(6 months)