Adjunctive, Low-dose tPA in Primary PCI for STEMI

Population Health Research Institute210 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

210

Conditions

Myocardial Infarction Percutaneous Coronary Intervention

Interventions

tissue plasminogen activatorDRUG

Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.

SalineOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with STEMI undergoing primary PCI and, 2. 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, 3. Randomization within 6 to 12 hours of symptom onset and, 4. Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing. Exclusion Criteria: 1. Active internal bleeding or high risk of bleeding or any prior intracranial bleeding. 2. Any other absolute or relative contraindication to fibrinolytic therapy. 3. Administration of a fibrinolytic ≤24hrs prior to randomization. 4. Cardiogenic shock on presentation. 5. Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study). 6. Planned upfront use of a glycoprotein IIb/IIIa inhibitor. 7. Any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.

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

Outcomes

Primary Outcomes

MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution

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.

Time frame: 30 days post-randomization

Secondary Outcomes

The Composite of MBG grade 0/1 or Distal Embolization or Failure to Achieve ≥50% ST-segment Resolution

* 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 of the summed absolute ST-segment deviations across associated and reciprocal leads at 30 minutes post-PCI

Time frame: 30 minutes post-PCI

The Composite of MBG grade 0/1 or Distal Embolization

Data from ClinicalTrials.gov

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