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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    200
  • sponsor
    Population Health Research Institute
Updated on 1 March 2022
clot
depression
thrombolytic
myocardial infarction
stemi
infarct
percutaneous coronary intervention
st elevation myocardial infarction
alteplase
tissue plasminogen activator

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.

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.

Details
Condition Myocardial Infarction, Percutaneous Coronary Intervention
Treatment Saline, Tissue Plasminogen Activator
Clinical Study IdentifierNCT03335839
SponsorPopulation Health Research Institute
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

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
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