Clinical trial NCT00806403: Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: thrombolysis
primary PCI
abciximab
ST-segment resolution
TIMI flow
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
name: Region Örebro County
name: Norra Alvsborgs Lans Hospital, Trollhattan
name: Varberg Hospital, Sweden
First posted: 2008-12-10
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%
timeFrame: 120 minutes after inclusion
measure: Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3
timeFrame: 5-7 days after inclusion
Secondary outcomes:
measure: Death
timeFrame: 30 days
measure: Reinfarction
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Orebro
country: Sweden
facility: Orebro University Hospital
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Trollhattan
country: Sweden
facility: Norra Alvsborgs lans Hospital
city: Varberg
country: Sweden
facility: Varberg Hospital
Study officials:
affiliation: Sahlgren's University Hospital/S
name: Lars Grip, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stockholm South General Hospital
name: Leif Svensson, M.D. PhD
role: STUDY_CHAIR
affiliation: Sahlgren's University Hospital/S
name: Johan Herlitz, M.D. PhD
role: STUDY_CHAIR
affiliation: Sahlgren's University Hospital/O
name: Mikael Dellborg, M.D. PhD
role: STUDY_CHAIR
affiliation: Stockholm South General Hospital
name: Ake Ohlsson, M.D. PhD
role: STUDY_CHAIR
affiliation: Stockholm South General Hospital
name: Mikael Aasa, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.