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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
 Drug: reteplase 10+10 U
Procedure: primary PCI
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 205
Study Start Date: November 2001
Study Completion Date: June 2004
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: thrombolysis Drug: reteplase 10+10 U
comparison to primary PCI
Other Name: Rapilysin
Active Comparator: invasive Procedure: primary PCI
comparison to thrombolysis
Other Name: primary percutaneous coronary intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806403

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Orebro University Hospital
Orebro, Sweden
Sodersjukhuset
Stockholm, Sweden
Norra Alvsborgs lans Hospital
Trollhattan, Sweden
Varberg Hospital
Varberg, Sweden
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Stockholm South General Hospital
University Hospital Orebro
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lars Grip, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier: NCT00806403     History of Changes
Other Study ID Numbers: SWEDES 23/09/01
Study First Received: November 7, 2008
Results First Received: November 7, 2008
Last Updated: December 2, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sahlgrenska University Hospital, Sweden:
thrombolysis
primary PCI
abciximab
ST-segment resolution
TIMI flow

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Heparin, Low-Molecular-Weight
 Dalteparin
Reteplase
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013