Phase 4
Completed N=205
Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction
Source: ClinicalTrials.gov NCT00806403 ↗Enrolled (actual)
205
Serious AEs
—
Results posted
Dec 2008
Primary outcomePrimary: Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% — 47; 51 participants — p=0.56
Summary
The main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% |
47; 51 | 0.56 |
| PRIMARY Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 |
35; 56 | 0.04 sig |
| SECONDARY Death |
4; 3 | 1.00 |
| SECONDARY Reinfarction |
2; 0 | 0.50 |
| SECONDARY Stroke |
3; 0 | 0.21 |
Eligibility Criteria
Inclusion Criteria
- Patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant ST-segment elevation on ECG.
Exclusion Criteria
- BP >180/110
- Known bleeding disorder
- Cardiogenic shock
- CPR>10 min
- Ongoing anticoagulant therapy
- Renal insufficiency
- Weight >120 kg
Data sourced from ClinicalTrials.gov (NCT00806403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.