Platelet Inhibition to Target Reperfusion Injury: The PITRI Trial
Overview
- Phase
- Phase 2
- Intervention
- Cangrelor
- Conditions
- STEMI
- Sponsor
- National Heart Centre Singapore
- Enrollment
- 228
- Locations
- 5
- Primary Endpoint
- Myocardial infarct size by CMR at Day 2 to 7
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cangrelor
Cangrelor (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
Intervention: Cangrelor
Placebo
Matching normal saline placebo (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
Intervention: Cangrelor
Outcomes
Primary Outcomes
Myocardial infarct size by CMR at Day 2 to 7
Time Frame: 2-7 days
This will be measured by CMR (mass of late gadolinium enhancement expressed as a percentage of the LV mass).
Secondary Outcomes
- 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)