Acute ST elevation myocardial infarction Circulatory System Acute myocardial infarction
Conditions
Interventions
Recruitment for this study began on the 1st February 2006. The completion of enrolment is expected in summer 2009.
The first 1,166 consecutive patients will enter the study set, while the further 584
the 12 U/kg/h infusion follows during the next 24 hours in uncomplicated patients or longer if clinically indicated. The dose is based on the activated Partial Thromboplastin Time (PTT). 40 mg proton-
a peroral treatment follows (40 mg pantoprazol/day or 50 mg ranitidine/day) during the next 2-3 days. Enoxiparin sodium (100 anti-Xa IU/kg every 12 hours) is used subcutaneously in patients under 75 y
Sponsors
Clinical Center of Serbia (Serbia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, 18 years of age or older 2. Chest discomfort persisting for more than 20 minutes 3. Presentation within 12 hours after the onset of symptoms 4. ST elevation in two contiguous leads of at least 0.2 mV in leads V2?V3 and/or of at least >0.1 mV in other leads, or new bundle branch block 5. Cardiac troponin exceeding upper reference limit at admission and/or 24 hours later
Exclusion criteria
Exclusion criteria: 1. Refusal to give consent for invasive treatment 2. Contraindications for dual antiplatelet therapy or contrast agents (active or recent internal bleeding, history of bleeding after non-steroid anti-inflammatory agents, known bleeding diathesis, allergy, intracerebral mass or aneurysm, platelet count of <100,000/mm^3 3. Cardiogenic shock at admission 4. Noncardiac conditions that could limit life expectancy to less than 1 year or that might interfere with compliance with the protocol (active cancer, significant liver or renal disease [creatinine clearance <30 ml/min], significant psychiatric disorders) 5. Planned elective surgery necessitating interruption of treatment with thienopyridines during the first 6 months after enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Risk score for composite major adverse cardiac events (MACE) including death, nonfatal reinfarction, ischaemic stroke and target vessel revascularisation (efficacy endpoint) 2. Risk score for major bleeding (safety endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Individual components of MACE 2. Stent thrombosis Safety: 3. Incidence of bleeding according to the TIMI and GUSTO classification 4. Need for transfusions 5. Withdrawal of dual antiplatelet therapy | — |
Countries
Serbia
Outcome results
None listed