Adjunctive, Low-dose tPA in Primary PCI for STEMI

Phase 3

Active, not recruiting

• Conditions: Percutaneous Coronary Intervention; Myocardial Infarction
• Interventions: Other: Saline; Drug: tissue plasminogen activator

• 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.

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Study Start: 2018-04-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-09-15
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 210

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.

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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.

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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
Post-procedural MBG 0/1 or Distal Embolization.	30 days	Composite of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.

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

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

University of Alberta - Mazankowski Alberta Heart Insitute; 🇨🇦 Edmonton, Alberta, Canada