Clinical trial NCT03335839: Adjunctive, Low-dose tPA in Primary PCI for STEMI
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Percutaneous Coronary Intervention
Keywords: tPA
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2017-11-08
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-procedural MBG 0/1 or Distal Embolization.
timeFrame: 30 days
Secondary outcomes:
measure: Complete ST-segment resolution.
timeFrame: 30 minutes
measure: CV Death, MI, Cardiogenic Shock or New Onset HF
timeFrame: 30 Days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary - Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta - Mazankowski Alberta Heart Insitute
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: McMaster University, Hamilton Health Sciences, Population Health Research Institute
name: Shamir Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References: