Adjunctive, Low-dose tPA in Primary PCI for STEMI

Myocardial Infarction Clinical Trial

— STRIVE  

Official title:

Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03335839
• Other study ID #: STRIVE.2018
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2018
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Population Health Research Institute
• Contact: Jennifer Cunningham
• Phone: 905-527-4322
• Email: strive[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

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

Other:
• Saline
Placebo

Locations

Country	Name	City	State
Canada	University of Calgary - Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta - Mazankowski Alberta Heart Insitute	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-procedural MBG 0/1 or Distal Embolization.	Composite of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.	30 days
Secondary	Complete ST-segment resolution.	Complete (=70%) ST-segment resolution (worst lead) at 30 minutes post-PCI	30 minutes
Secondary	CV Death, MI, Cardiogenic Shock or New Onset HF	Composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure.	30 Days