Adjunctive, Low-dose tPA in Primary PCI for STEMI
- Conditions
- Myocardial InfarctionPercutaneous Coronary Intervention
- Registration Number
- NCT03335839
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria:<br><br> 1. Patients with STEMI undergoing primary PCI and,<br><br> 2. ECG changes indicating large territory STEMI (defined as =2mm ST-segment elevation<br> in 2 contiguous anterior precordial leads; or =2mm ST-segment elevation in 2<br> inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for<br> a total ST-segment deviation of =8mm) and,<br><br> 3. Randomization within 6 to 12 hours of symptom onset and,<br><br> 4. Large thrombus burden with angiographic TIMI Thrombus Grade =3 after guidewire<br> crossing.<br><br>Exclusion Criteria:<br><br> 1. Active internal bleeding or high risk of bleeding or any prior intracranial<br> bleeding.<br><br> 2. Any other absolute or relative contraindication to fibrinolytic therapy.<br><br> 3. Administration of a fibrinolytic =24hrs prior to randomization.<br><br> 4. Cardiogenic shock on presentation.<br><br> 5. Left bundle branch block (excluded because the ECG cannot be evaluated for ST<br> segment resolution, an outcome of the study).<br><br> 6. Planned upfront use of a glycoprotein IIb/IIIa inhibitor.<br><br> 7. Any medical, geographic, or social factor making study participation impractical or<br> precluding 1 month follow-up.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post-procedural MBG 0/1 or Distal Embolization.
- Secondary Outcome Measures
Name Time Method Complete ST-segment resolution.;CV Death, MI, Cardiogenic Shock or New Onset HF