Acute myocardial infaction with ST elevation Circulatory System Acute myocardial infarction
Conditions
Interventions
Before pPCI, 300 mg aspirin and 600 mg clopidogrel loading doses will be administered. Unfractionated heparin is started as 100 IU/kg bolus (60 IU/kg if glycoprotein (GP) IIb/IIIa receptor inhibitor w
the 12 IU/kg/h infusion followed if clinically indicated (atrial fibrillation, left ventricular (LV) thrombus or aneurysm, recent or recurrent venous thromboembolism, deferred sheath removal). Proton-
Sponsors
Clinical Center of Serbia (Serbia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with intermediate to high risk for 30-day Major Adverse Cardiac Events (MACE) (RISK-PCI score >3) undergoing primary PCI with stent implantation within 12 hours of the onset of symptoms 2. Ability to comply with study protocol 3. Negative test for pregnancy for women of childbearing potential before enrollment and agreement to use a reliable method of birth control during the study
Exclusion criteria
Exclusion criteria: Pre-procedural: 1. Any history of hemorrhagic stroke 2. Ischemic stroke within 30 days of randomization 3. Evidence of active abnormal bleeding within 3 months of randomization 4. High risk for bleeding on long-term clopidogrel therapy 5. Current therapy with coumadin anticoagulation 6. Pregnancy or nursing 7. Current enrollment in another investigational drug or device study Procedural: 1. Balloon angioplasty without stent placement 2. Unsuccessful pPCI (post-procedural TIMI flow 0) Post-procedural: 1. Died within 24 hours after loading dose 2. Active internal bleeding 3. Hemoglobin < 10 g/dL or drop in hemoglobin by =3 g/dL 4. Platelet count < 100 000 x 10-9/L. 5. Thrombin Receptor Activating Peptide (TRAP) value <500 AU 6. Indication for permanent anticoagulant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to the first of composite events including death, nonfatal infarction, stroke or definite subacute stent thrombosis. Major safety end points includeTIMI major bleeding unrelated to coronary artery bypass graft surgery. Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individual components of MACE 2. Total bleeding and the need for blood transfusions Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment. | — |
Countries
Serbia
Outcome results
None listed