Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction

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

Official Title
-----------------
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

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: reteplase 10+10 U
* Procedure: primary PCI


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: thrombolysis<br> | Drug: reteplase 10+10 U<br>* comparison to primary PCI<br>* Other names: Rapilysin;|
| Active Comparator: invasive<br> | Procedure: primary PCI<br>* comparison to thrombolysis<br>* Other names: primary percutaneous coronary intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% | ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion | 120 minutes after inclusion | 
| Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 | Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion. | 5-7 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 30 days | 
| Reinfarction |  | 30 days | 
| Stroke |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary PCI, thrombolysis, abciximab, ST-segment resolution, TIMI flow