VERDIDosis de carga de Prasugrel vs Dosis estándar de Clopidogrel en pacientes con diabetes tipo 2 y síndrome coronario agudo

Fecha de inicio: 1 de octubre de 2012

Inclusion Criteria: Type 2 diabetic patients with acute coronary syndrome with non-ST segment elevation who are undergoing a percutaneous coronary intervention (PCI) with a coronary stent. Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized. Participants must sign an informed consent document. Exclusion Criteria: Age <18 years or >80 years. Patients with acute coronary syndrome with ST segment elevation. Pregnancy previous to or during the study. The use of oral anticoagulants in the last 10 days with an INR >1.5 or who plan to use them during the follow-up period (1 year). Antithrombotic treatment with GP IIb/IIIa inhibitors. Contraindication for the use of prasugrel and/or clopidogrel and/or aspirin: Antecedents of pharmacologic allergy to thienopyridine derivatives or aspirin. Antecedents of clinically significant or persistent thrombocytopenia or neutropenia. Active bleeding or significant increase of risk of hemorrhage such as severe hepatic insufficiency, peptic ulcer present, proliferative diabetic retinopathy, antecedents of severe systemic bleeding, gastrointestinal bleeding, macrohematuria, intraocular hemorrhage, hemorrhagic stroke, or intracranial bleeding), or other antecedents of bleeding diathesis or coagulopathy. Patients with previous TIA or CVA. Patients weighing <60 Kg. Hemoglobin <10.5 g/dl, or Hematocrit <30%. Severe left ventricular systolic dysfunction, EF <35%. Renal insufficiency with creatinine levels >2 mg/dl. Previous inclusion of the patient in another study. Treatment in research (medication or device) in the last 30 days prior. Medical, geographical, or social factors that would make participation in the study impractical, such as the incapacity to provide written informed consent and to understand the complete meaning of informed consent, or the refusal of the patient to participate in the study.