Adjunctive, Low-dose tPA in Primary PCI for STEMI
- Conditions
- Percutaneous Coronary InterventionMyocardial Infarction
- Interventions
- Other: Saline
- Registration Number
- NCT03335839
- Lead Sponsor
- Population Health Research Institute
- 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 infarction (STEMI) in reducing the incidence of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.
- 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 cardiovascular events using intracoronary administration of very low-dose fibrinolytic (tissue plasminogen activator, tPA) directly into the culprit coronary artery during primary PCI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Saline saline Intracoronary tPA 20 mg tissue plasminogen activator - Intracoronary tPA 10 mg tissue plasminogen activator -
- Primary Outcome Measures
Name Time Method MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution 30 days post-randomization The primary efficacy variable is the binary composite outcome with the following components:
* The occurrence of any of the MACE outcomes (cardiovascular death, myocardial re-infarction, cardiogenic shock and new onset heart failure) at 30 days post-randomization.
* Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent "staining", suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)).
* Post-procedural Distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI).
* Failure to achieve ≥50% ST-segment resolution post-procedure.
- Secondary Outcome Measures
Name Time Method Complete ST-segment Resolution. 30 minutes Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI
CV Death, MI, Cardiogenic Shock or New Onset HF 30 Days Composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure.
Trial Locations
- Locations (3)
University of Calgary - Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
University of Alberta - Mazankowski Alberta Heart Insitute
🇨🇦Edmonton, Alberta, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
University of Calgary - Foothills Medical Centre🇨🇦Calgary, Alberta, Canada