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| Name | Class |
|---|---|
| Stockholm South General Hospital | OTHER |
| Region Örebro County | OTHER |
| Norra Alvsborgs Lans Hospital, Trollhattan | UNKNOWN |
| Varberg Hospital, Sweden |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thrombolysis | Active Comparator |
| |
| invasive | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reteplase 10+10 U | Drug | comparison to primary PCI |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 120 minutes after 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. | 5-7 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 30 days | |
| Reinfarction | 30 days | |
| Stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Grip, M.D. PhD | Sahlgren's University Hospital/S | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Sweden | ||||
| Orebro University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16569536 | Result | 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. | |
| 17925603 |
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From Nov. 2001 to May 2003. Cardiology Departments
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Invasive |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
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| primary PCI | Procedure | comparison to thrombolysis |
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| 30 days |
| Örebro |
| Sweden |
| Sodersjukhuset | Stockholm | Sweden |
| Norra Alvsborgs lans Hospital | Trollhättan | Sweden |
| Varberg Hospital | Varberg | Sweden |
| Result |
| 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. |
| 20691839 | Derived | 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. |
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.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis was made on intention to treat(ITT) basis.Patients with electrocardiograms (ECGs) suitable for analysis at inclusion and at 120 minutes therafter were included in the analysis. | Posted | Number | participants | 120 minutes after inclusion |
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| Secondary | Death | Analysis was made on intention to treat (ITT) basis. | Posted | Number | participants | 30 days |
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| Primary | 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. | Patient were analyzed on intention to treat (ITT) basis. The per protocol angiography on day 5-7 after inclusion was used for analysis of Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related coronary artery. | Posted | Number | participants | 5-7 days after inclusion |
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| Secondary | Reinfarction | Analysis made on intention to treat (ITT) basis. | Posted | Number | Participants | 30 days |
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| Secondary | Stroke | Analysis made on intention to treat (ITT) basis. | Posted | Number | Participants | 30 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lars Grip | Sahlgren's University Hospital/S, Gothenburg | lars.grip@vgregion.se |
| ID | Term |
|---|---|
| C087896 | reteplase |
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| >=65 years |
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| Male |
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| Participants |
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