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

This study has been completed.
Sponsor:
Collaborators:
Stockholm South General Hospital
University Hospital Orebro
Norra Alvsborgs Lans Hospital, Trollhattan
Varberg Hospital, Sweden
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00806403
First received: November 7, 2008
Last updated: December 2, 2008
Last verified: November 2008

November 7, 2008
December 2, 2008
November 2001
June 2003   (final data collection date for primary outcome measure)
  • Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 [ Time Frame: 5-7 days after inclusion ] [ Designated as safety issue: No ]
  • Number of Patients With ST-Segment Elevation Resolution Equal or More Than 50% [ Time Frame: 120 minutes after inclusion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806403 on ClinicalTrials.gov Archive Site
  • Reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: reteplase 10+10 U
    comparison to primary PCI
    Other Name: Rapilysin
  • Procedure: primary PCI
    comparison to thrombolysis
    Other Name: primary percutaneous coronary intervention
  • Active Comparator: thrombolysis
    Intervention: Drug: reteplase 10+10 U
  • Active Comparator: invasive
    Intervention: Procedure: primary PCI

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
June 2004
June 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00806403
SWEDES 23/09/01
Yes
Lars Grip, Sahlgrenska University Hospital
Sahlgrenska University Hospital, Sweden
  • Stockholm South General Hospital
  • University Hospital Orebro
  • Norra Alvsborgs Lans Hospital, Trollhattan
  • Varberg Hospital, Sweden
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
Sahlgrenska University Hospital, Sweden
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP