NCT00806403

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	reteplase 10+10 U	comparison to primary PCI
PROCEDURE	primary PCI	comparison to thrombolysis

Timeline

• Start date: 2001-11-01
• Primary completion: 2003-06-01
• Completion: 2004-06-01
• First posted: 2008-12-10
• Last updated: 2008-12-10
• Results posted: 2008-12-10

Locations

5 sites across 1 country: Sweden