Status:
COMPLETED
Adjunctive, Low-dose tPA in Primary PCI for STEMI
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Conditions:
Myocardial Infarction
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
STRIVE will evaluate the use of adjunctive, low-dose intracoronary tissue plasminogen activator during primary percutaneous coronary intervention (PCI) for patients with ST elevation myocardial infarc...
Detailed Description
STRIVE is a prospective, 3-arm, parallel group, blinded, randomized controlled trial evaluating the efficacy of a novel approach to prevent and treat microvascular obstruction thereby reducing major c...
Eligibility Criteria
Inclusion
- Patients with STEMI undergoing primary PCI and,
- ECG changes indicating large territory STEMI (defined as ≥2mm ST-segment elevation in 2 contiguous anterior precordial leads; or ≥2mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥8mm) and,
- Randomization within 6 to 12 hours of symptom onset and,
- Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing.
Exclusion
- Active internal bleeding or high risk of bleeding or any prior intracranial bleeding.
- Any other absolute or relative contraindication to fibrinolytic therapy.
- Administration of a fibrinolytic ≤24hrs prior to randomization.
- Cardiogenic shock on presentation.
- Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study).
- Planned upfront use of a glycoprotein IIb/IIIa inhibitor.
- Any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03335839
Start Date
April 1 2018
End Date
February 12 2025
Last Update
September 26 2025
Active Locations (3)
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1
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4Z6
2
University of Alberta - Mazankowski Alberta Heart Insitute
Edmonton, Alberta, Canada, T6G 2B7
3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2