Adjunctive, Low-dose tPA in Primary PCI for STEMI

Study Overview
=================
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.

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

Conditions
-----------------
Myocardial Infarction, Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Drug: tissue plasminogen activator
* Other: Saline


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tPA