Adjunctive, Low-dose tPA in Primary PCI for STEMI

NCT ID: NCT03335839

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2025-02-12

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.

Conditions

Myocardial Infarction; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intracoronary tPA 10 mg

Group Type: EXPERIMENTAL

tissue plasminogen activator

Intervention Type: DRUG

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

Intracoronary tPA 20 mg

Group Type: EXPERIMENTAL

tissue plasminogen activator

Intervention Type: DRUG

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

Placebo

saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Placebo

Interventions

tissue plasminogen activator

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

Intervention Type: DRUG

Saline

Placebo

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shamir Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Hamilton Health Sciences, Population Health Research Institute

Locations

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

Countries

Canada

Other Identifiers

STRIVE.2018

Identifier Type: -

Identifier Source: org_study_id