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

Phase 4

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: reteplase 10+10 U; Procedure: primary PCI

• Registration Number: NCT00806403
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2003-06
• Study Completion: 2004-06
• Status Verified: 2008-11
• Study First Submitted: 2008-11-07
• Results First Submitted: 2008-11-07
• Study First Submitted QC: 2008-12-02
• Results First Submitted QC: 2008-12-02
• Last Update Submitted: 2008-12-02
• Study First Posted: 2008-12-10
• Results First Posted: 2008-12-10
• Last Update Posted: 2008-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thrombolysis	reteplase 10+10 U	-
invasive	primary PCI	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Death	30 days
Reinfarction	30 days
Stroke	30 days

Trial Locations

Locations (5)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Orebro University Hospital; 🇸🇪 Orebro, Sweden

Sodersjukhuset; 🇸🇪 Stockholm, Sweden

Norra Alvsborgs lans Hospital; 🇸🇪 Trollhattan, Sweden

Varberg Hospital; 🇸🇪 Varberg, Sweden