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: Completed
• 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 (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary - Foothills Medical Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta - Mazankowski Alberta Heart Insitute
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton General Hospital

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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Composite of MBG grade 0/1 or Distal Embolization or Failure to Achieve ≥50% ST-segment Resolution	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 of the summed absolute ST-segment deviations across associated and reciprocal leads at 30 minutes post-PCI	30 minutes post-PCI
The Composite of MBG grade 0/1 or Distal Embolization	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).	Immediately following PCI
MBG Grade 0/1	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)).	Immediately following PCI
Distal Embolization	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.	Immediately following PCI
Failure to Achieve ≥50% ST-segment Resolution.	Failure to achieve ≥50% ST-segment resolution of the summed absolute ST-segment deviations across associated and reciprocal leads at 30 minutes post-PCI.	30 minutes post-PCI
Time to the First Occurrence of MACE	Time to the first occurrence of MACE (composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure) over the duration of 30 days follow-up.	30 days post-randomization

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): September 17, 2024
• Study Completion (Actual): February 12, 2025

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 (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: tPA
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Blood Proteins; Inorganic Chemicals; Chlorine Compounds; Endopeptidases; Peptide Hydrolases; Sodium Compounds; Serine Endopeptidases; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Chlorides; Hydrochloric Acid; Tissue Plasminogen Activator; Sodium Chloride
• 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