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

Primary Purpose

Myocardial Infarction, Percutaneous Coronary Intervention

Status

Recruiting

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

tissue plasminogen activator

Saline

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring tPA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Hamilton General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Intracoronary tPA 10 mg

Intracoronary tPA 20 mg

Placebo

Arm Description

saline

Outcomes

Primary Outcome Measures

Post-procedural MBG 0/1 or Distal Embolization.

Composite of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.

Secondary Outcome Measures

Complete ST-segment resolution.

Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI

CV Death, MI, Cardiogenic Shock or New Onset HF

Composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure.

Full Information

NCT ID

NCT03335839

First Posted

November 3, 2017

Last Updated

August 24, 2023

Sponsor

Population Health Research Institute

Collaborators

Heart and Stroke Foundation of Canada

1. Study Identification

Unique Protocol Identification Number

NCT03335839

Brief Title

Adjunctive, Low-dose tPA in Primary PCI for STEMI

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Population Health Research Institute

Collaborators

Heart and Stroke Foundation of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Percutaneous Coronary Intervention

Keywords

tPA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intracoronary tPA 10 mg

Arm Type

Experimental

Arm Title

Intracoronary tPA 20 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

saline

Intervention Type

Drug

Intervention Name(s)

tissue plasminogen activator

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Post-procedural MBG 0/1 or Distal Embolization.

Description

Composite of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Complete ST-segment resolution.

Description

Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI

Time Frame

30 minutes

Title

CV Death, MI, Cardiogenic Shock or New Onset HF

Description

Composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure.

Time Frame

30 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Cunningham

Phone

905-527-4322

strive@phri.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Tara McCready, PhD, MBA

Phone

905-527-4322

strive@phri.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shamir Mehta, MD

Organizational Affiliation

McMaster University, Hamilton Health Sciences, Population Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L2X2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

STRIVE Investigator

Phone

9055274322

strive@phri.ca

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Adjunctive, Low-dose tPA in Primary PCI for STEMI

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