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

December 2, 2008 updated by: Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Orebro, Sweden
        • Orebro University Hospital
      • Stockholm, Sweden
        • Sodersjukhuset
      • Trollhattan, Sweden
        • Norra Alvsborgs lans Hospital
      • Varberg, Sweden
        • Varberg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: thrombolysis
Drug: reteplase 10+10 U
comparison to primary PCI
Other Names:
  • Rapilysin
ACTIVE_COMPARATOR: invasive
Procedure: primary PCI
comparison to thrombolysis
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%
Time Frame: 120 minutes after inclusion
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
Time Frame: 5-7 days after inclusion
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
Time Frame
Stroke
Time Frame: 30 days
30 days
Death
Time Frame: 30 days
30 days
Reinfarction
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Region Örebro County
Stockholm South General Hospital
Norra Alvsborgs Lans Hospital, Trollhattan
Varberg Hospital, Sweden

Investigators

  • Principal Investigator: Lars Grip, M.D. PhD, Sahlgren's University Hospital/S
  • Study Chair: Leif Svensson, M.D. PhD, Stockholm South General Hospital
  • Study Chair: Johan Herlitz, M.D. PhD, Sahlgren's University Hospital/S
  • Study Chair: Mikael Dellborg, M.D. PhD, Sahlgren's University Hospital/O
  • Study Chair: Ake Ohlsson, M.D. PhD, Stockholm South General Hospital
  • Study Chair: Mikael Aasa, M.D., Stockholm South General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (ACTUAL)

June 1, 2003

Study Completion (ACTUAL)

June 1, 2004

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2008

Last Update Submitted That Met QC Criteria

December 2, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWEDES 23/09/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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