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

Acute Myocardial Infarction Clinical Trial

— SWEDES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806403
• Other study ID #: SWEDES 23/09/01
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2008
• Last updated: December 2, 2008
• Start date: November 2001
• Est. completion date: June 2004

Study information

• Verified date: November 2008
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: June 2004
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• reteplase 10+10 U
comparison to primary PCI

Procedure:
• primary PCI
comparison to thrombolysis

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Orebro University Hospital	Orebro
Sweden	Sodersjukhuset	Stockholm
Sweden	Norra Alvsborgs lans Hospital	Trollhattan
Sweden	Varberg Hospital	Varberg

Sponsors (5)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Norra Alvsborgs Lans Hospital, Trollhattan, Stockholm South General Hospital, University Hospital Orebro, Varberg Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Aasa M, Kirtane AJ, Dellborg M, Gibson MC, Prahl-Abrahamsson U, Svensson L, Grip L. Temporal changes in TIMI myocardial perfusion grade in relation to epicardial flow, ST-resolution and left ventricular function after primary percutaneous coronary interve — View Citation

Svensson L, Aasa M, Dellborg M, Gibson CM, Kirtane A, Herlitz J, Ohlsson A, Karlsson T, Grip L. Comparison of very early treatment with either fibrinolysis or percutaneous coronary intervention facilitated with abciximab with respect to ST recovery and in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3		5-7 days after inclusion	No
Primary	Number of Patients With ST-Segment Elevation Resolution Equal or More Than 50%		120 minutes after inclusion	No
Secondary	Reinfarction		30 days	No
Secondary	Death		30 days	Yes
Secondary	Stroke		30 days	Yes