Adjunctive, Low-dose tPA in Primary PCI for STEMI (STRIVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: tissue plasminogen activator; Other: Saline

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jennifer Cunningham; Phone Number: 905-527-4322; Email: strive@phri.ca
• Study Contact Backup: Name: Tara McCready, PhD, MBA; Phone Number: 905-527-4322; Email: strive@phri.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Recruiting
      • University of Calgary - Foothills Medical Centre
      • Contact: STRIVE Investigator; Phone Number: 905-527-4322; Email: strive@phri.ca
      • Principal Investigator: Bryan Har, MD, FRCPC, MPH
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta - Mazankowski Alberta Heart Insitute
      • Contact: STRIVE Investigator; Phone Number: 905-527-4322; Email: strive@phri.ca
      • Principal Investigator: Kevin Bainey, MD, MSc, FRCPC, FACC
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Recruiting
      • Hamilton General Hospital
      • Contact: STRIVE Investigator; Phone Number: 9055274322; Email: strive@phri.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracoronary tPA 10 mg	Drug: tissue plasminogen activator; Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.
Experimental: Intracoronary tPA 20 mg	Drug: tissue plasminogen activator; Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.
Placebo Comparator: Placebo; saline	Other: Saline; Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ST-segment resolution.	Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI	30 minutes
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

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: Shamir Mehta, MD, McMaster University, Hamilton Health Sciences, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: tPA
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: STRIVE.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No