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
Results First Received: November 7, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myocardial Infarction
Interventions: Drug: reteplase 10+10 U
Procedure: primary PCI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From Nov. 2001 to May 2003. Cardiology Departments

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Thrombolysis Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
Invasive 500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.

Participant Flow:   Overall Study
    Thrombolysis     Invasive  
STARTED     104     101  
COMPLETED     100     98  
NOT COMPLETED     4     3  
Death                 4                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Thrombolysis Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
Invasive 500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Total Total of all reporting groups

Baseline Measures
    Thrombolysis     Invasive     Total  
Number of Participants  
[units: participants]
  104     101     205  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     55     49     104  
>=65 years     49     52     101  
Age  
[units: years]
Mean ± Standard Deviation
  64.3  ± 12.4     65.3  ± 10.9     64.8  ± 11.7  
Gender  
[units: participants]
     
Female     26     27     53  
Male     78     74     152  
Region of Enrollment  
[units: participants]
     
Sweden     104     101     205  



  Outcome Measures
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1.  Primary:   Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%   [ Time Frame: 120 minutes after inclusion ]

2.  Primary:   Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3   [ Time Frame: 5-7 days after inclusion ]

3.  Secondary:   Death   [ Time Frame: 30 days ]

4.  Secondary:   Reinfarction   [ Time Frame: 30 days ]

5.  Secondary:   Stroke   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lars Grip
Organization: Sahlgren's University Hospital/S, Gothenburg
e-mail: lars.grip@vgregion.se


Publications of Results:
Publications automatically indexed to this study:

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