Adjunctive, Low-dose tPA in Primary PCI for STEMI

NCT03335839 | Completed Phase 3 DMC

• 1 other identifier: STRIVE.2018
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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.

Conditions

Myocardial Infarction; Percutaneous Coronary Intervention

Keywords

tPA

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days post-randomization

Secondary Outcomes (2)

• Complete ST-segment Resolution.

  30 minutes

• CV Death, MI, Cardiogenic Shock or New Onset HF

  30 Days

Study Arms (3)

Intracoronary tPA 10 mg

EXPERIMENTAL

Drug: tissue plasminogen activator

Intracoronary tPA 20 mg

EXPERIMENTAL

Drug: tissue plasminogen activator

Placebo

PLACEBO COMPARATOR

saline

Other: Saline

Interventions

tissue plasminogen activator DRUG

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

Intracoronary tPA 10 mg; Intracoronary tPA 20 mg

Saline OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (3)

University of Calgary - Foothills Medical Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta - Mazankowski Alberta Heart Insitute

Edmonton, Alberta, T6G 2B7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Related Publications (1)

• Mehta SR, Pinilla-Echeverri N, Tiong D, Kovalova T, Sheth T, Natarajan MK, Sibbald M, Velianou JL, Welsh R, Har B, Jolly SS, Valettas N, Schwalm JD, Tsang M, Khatun R, Mian R, Cunningham J, Ly E, McCready T, Bainey KR. Intracoronary Low-Dose Recombinant Tissue Plasminogen Activator in Primary PCI for ST-Segment Elevation Myocardial Infarction and Large Thrombus Burden: A Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):238-248. doi: 10.1016/j.jacc.2025.10.008. Epub 2025 Oct 28.

  PMID: 41194755 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Tissue Plasminogen Activator; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shamir Mehta, MD

  McMaster University, Hamilton Health Sciences, Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 8, 2017
• Study Start: April 1, 2018
• Primary Completion: September 17, 2024
• Study Completion: February 12, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CA (3)