Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction (SWEDES)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
reteplase 10+10 U
primary PCI
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring thrombolysis, primary PCI, abciximab, ST-segment resolution, TIMI flow
Eligibility 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
Sites / Locations
- Sahlgrenska University Hospital
- Orebro University Hospital
- Sodersjukhuset
- Norra Alvsborgs lans Hospital
- Varberg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
thrombolysis
invasive
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%
ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion
Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3
Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.
Secondary Outcome Measures
Death
Reinfarction
Stroke
Full Information
NCT ID
NCT00806403
First Posted
November 7, 2008
Last Updated
December 2, 2008
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Stockholm South General Hospital, Region Örebro County, Norra Alvsborgs Lans Hospital, Trollhattan, Varberg Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00806403
Brief Title
Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction
Acronym
SWEDES
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 Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Stockholm South General Hospital, Region Örebro County, Norra Alvsborgs Lans Hospital, Trollhattan, Varberg Hospital, Sweden
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
thrombolysis, primary PCI, abciximab, ST-segment resolution, TIMI flow
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
thrombolysis
Arm Type
Active Comparator
Arm Title
invasive
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
reteplase 10+10 U
Other Intervention Name(s)
Rapilysin
Intervention Description
comparison to primary PCI
Intervention Type
Procedure
Intervention Name(s)
primary PCI
Other Intervention Name(s)
primary percutaneous coronary intervention
Intervention Description
comparison to thrombolysis
Primary Outcome Measure Information:
Title
Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%
Description
ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion
Time Frame
120 minutes after inclusion
Title
Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3
Description
Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.
Time Frame
5-7 days after inclusion
Secondary Outcome Measure Information:
Title
Death
Time Frame
30 days
Title
Reinfarction
Time Frame
30 days
Title
Stroke
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Grip, M.D. PhD
Organizational Affiliation
Sahlgren's University Hospital/S
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leif Svensson, M.D. PhD
Organizational Affiliation
Stockholm South General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johan Herlitz, M.D. PhD
Organizational Affiliation
Sahlgren's University Hospital/S
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mikael Dellborg, M.D. PhD
Organizational Affiliation
Sahlgren's University Hospital/O
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ake Ohlsson, M.D. PhD
Organizational Affiliation
Stockholm South General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mikael Aasa, M.D.
Organizational Affiliation
Stockholm South General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Orebro University Hospital
City
Orebro
Country
Sweden
Facility Name
Sodersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Norra Alvsborgs lans Hospital
City
Trollhattan
Country
Sweden
Facility Name
Varberg Hospital
City
Varberg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
16569536
Citation
Svensson L, Aasa M, Dellborg M, Gibson CM, Kirtane A, Herlitz J, Ohlsson A, Karlsson T, Grip L. Comparison of very early treatment with either fibrinolysis or percutaneous coronary intervention facilitated with abciximab with respect to ST recovery and infarct-related artery epicardial flow in patients with acute ST-segment elevation myocardial infarction: the Swedish Early Decision (SWEDES) reperfusion trial. Am Heart J. 2006 Apr;151(4):798.e1-7. doi: 10.1016/j.ahj.2005.09.013.
Results Reference
result
PubMed Identifier
17925603
Citation
Aasa M, Kirtane AJ, Dellborg M, Gibson MC, Prahl-Abrahamsson U, Svensson L, Grip L. Temporal changes in TIMI myocardial perfusion grade in relation to epicardial flow, ST-resolution and left ventricular function after primary percutaneous coronary intervention. Coron Artery Dis. 2007 Nov;18(7):513-8. doi: 10.1097/MCA.0b013e3282c1fdb6.
Results Reference
result
PubMed Identifier
20691839
Citation
Aasa M, Henriksson M, Dellborg M, Grip L, Herlitz J, Levin LA, Svensson L, Janzon M. Cost and health outcome of primary percutaneous coronary intervention versus thrombolysis in acute ST-segment elevation myocardial infarction-Results of the Swedish Early Decision reperfusion Study (SWEDES) trial. Am Heart J. 2010 Aug;160(2):322-8. doi: 10.1016/j.ahj.2010.05.008.
Results Reference
derived
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Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction
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