Platelet Inhibition to Target Reperfusion Injury (PITRI)
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|ClinicalTrials.gov Identifier: NCT03102723|
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|STEMI||Drug: Cangrelor||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Platelet Inhibition to Target Reperfusion Injury: The PITRI Trial|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Cangrelor (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
Other Name: Kengreal
Placebo Comparator: Placebo
Matching normal saline placebo (single intravenous bolus followed by a 120-minute infusion) initiated prior to PPCI.
Other Name: Kengreal
- 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).
- Microvascular obstruction to calculate myocardial interstitial volume [ Time Frame: 2-7 days ]This will be assessed by CMR performed at 2-7 days post-PPCI
- Myocardial salvage index [ Time Frame: 2-7 days ]This will be assessed by cardiac magnetic resonance (CMR) performed at 2-7 days post-PPCI by measuring MI size and the area at risk
- Angiographic markers of successful reperfusion [ Time Frame: 2 to 3 hours ]ST-segment resolution 90 min post-PPCI, TIMI flow and frame-count post-PPCI, and TIMI blush grade
- Myocardial infarct size by CMR at 6 months [ Time Frame: 6 months ]This will be measured by Cardiac MRI 6 months post-PPCI
- Post-MI LV remodeling by measuring LV ejection fraction and indexed LV end systolic and diastolic volumes and mass [ Time Frame: 6 months ]This will be assessed by CMR by measuring LV ejection fraction and indexed LV end systolic and diastolic volumes and mass.
- Platelet function testing [ Time Frame: 2 hours ]Serial platelet function testing will be performed with VerifyNow in a subset of 70 patients.
- MACCE at 30 days, at 6 months, at 12 months, at 24 months, at 5 years and at 10 years [ Time Frame: 6 months ]This will include all-cause death, hospitalisation for heart failure (HHF), stent thrombosis, ischemia-induced coronary revascularisation, re-infarction, and stroke. This data will be collected by telephone and reviewing medical notes at 30 days and at the time of the outpatient 6 month cardiac MR scan.
- Incidence of definite stent thrombosis at 48 hours [ Time Frame: 48 hours ]This will be defined according to the criteria of the Academic Research Consortium, which was assessed, with group assignments concealed, at an angiographic core laboratory (Cardiovascular Research Foundation).
- Quality of life questionnaire [ Time Frame: 6 months ]The EuroQol EQ-5D Health-Related Quality of Life (EUROQOL) questionnaire (www.euroqol.org) will be used to assess patient quality of life post-CABG with or without valve surgery, at baseline (1 day post-PPCI), 30 days (by telephone), and 6 months (at time of outpatient CMR scan).
- 6-Minute Walk Test (6MWT) [ Time Frame: 6 months ]Functional capacity of patients will be measured using the 6-Minute Walk Test
- Subjective questionnaire [ Time Frame: 6 months ]Subjective questionnaire relating to symptoms post angioplasty and physical activities will be assess at 30±7 days (by telephone), and at 6±1 months (at time of the outpatient CMR scan).
- ALDH2 substudy [ Time Frame: 6 months ]A saliva sample will be collected from a sub-group of subjects for determination of their ALDH2 genotype.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102723
|Contact: Derek John Hausenloy||6704 2196 ext firstname.lastname@example.org|
|Contact: Katherina Oh||6704 ext email@example.com|
|National University Hospital (NUH)||Recruiting|
|Singapore, Singapore, 119228|
|Contact: A/Prof Mark Chan 67795555|
|Contact: Sock Cheng Poh firstname.lastname@example.org|
|Tan Tock Seng Hospital (TTSH)||Recruiting|
|Singapore, Singapore, 308433|
|Contact: Dr. Hee Hwa Ho 63577831|
|Contact: Tasha Mahadi AB 63578124 email@example.com|
|Khoo Teck Puat Hospital||Not yet recruiting|
|Singapore, Singapore, 768828|
|Contact: Lim Boon Khim 66023307|
|Principal Investigator: Imran Syed Saqib|
|Principal Investigator:||Derek John Hausenloy||National Heart Centre Singapore|