Title
Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction
Very Early Initiation of Treatment With Thrombolysis and Low Molecular Weight Heparin, Versus Abciximab and Low Molecular Weight Heparin Followed by Percutaneous Coronary Intervention, for Acute ST-Elevation Myocardial Infarction
Phase
Phase 4Lead Sponsor
University of GothenburgStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Acute Myocardial InfarctionIntervention/Treatment
reteplase ...Study Participants
205The 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.
Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay.
Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute).
Secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days.
Data on use of health care resources, loss of production and health-related quality of life were collected during one year. Cost-effectiveness was determined by comparing costs and quality-adjusted survival.
comparison to primary PCI
comparison to thrombolysis
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
| Event Type | Organ System | Event Term |
|---|
ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion
Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.
