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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00806403
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : December 10, 2008
Last Update Posted : December 10, 2008
Information provided by:

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2001
Primary Completion Date : June 2003
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Reteplase
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 [ Time Frame: 5-7 days after inclusion ]
  2. Number of Patients With ST-Segment Elevation Resolution Equal or More Than 50% [ Time Frame: 120 minutes after inclusion ]

Secondary Outcome Measures :
  1. Reinfarction [ Time Frame: 30 days ]
  2. Death [ Time Frame: 30 days ]
  3. Stroke [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806403

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

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
First Posted: December 10, 2008    Key Record Dates
Results First Posted: December 10, 2008
Last Update Posted: December 10, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors