Type 2 diabetic patients revascularized with a stent, who have an acute coronary syndrome without persistent ST segment elevation.
Conditions
Interventions
Trade Name: Efient
Product Name: Efient
Pharmaceutical Form: Tablet
INN or Proposed INN: PRASUGREL
CAS Number: 150322-43-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Fundación FISEVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized. 3. Participants must sign an informed consent document. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Age 80 years. 2. Patients with acute coronary syndrome with ST segment elevation. 3. Pregnancy previous to or during the study. 4. 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). 5. Antithrombotic treatment with GP IIb/IIIa inhibitors. 6. 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. 7. 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. 8. Patients >75 years of age. 9. Patients with previous TIA or CVA. 10. Patients weighing 2 mg/dl. 14. Previous inclusion of the patient in another study. 15. Treatment in research (medication or device) in the last 30 days prior. 16. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.;Secondary Objective: To evaluate the safety of a treatment plan with a loading dose of prasugrel in comparison with the treatment plan of the standard dose of clopidogrel in terms of the appearance of secondary effects of clopidogrel (severe bleeding, thrombocytopenia, neutropenia, gastrointestinal changes, thrombotic thrombocytopenic purpura).;Primary end point(s): Level of platelet aggregation inhibition at 24-36 hours post-PCI (Percutaneous Coronary Interventionism)in both groups (standar dose of clopidogrel vs loading dose of 60 mg of prasugrel followed by 10 mg daily). The level of platelet aggregation inhibition will be assessed by VerifyNow assay.;Timepoint(s) of evaluation of this end point: 24-36 hours post-PCI (Percutaneous Coronary Interventionism | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence and severity of adverse events.;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Spain
Contacts
Public ContactClara Rosso Fernández
Fundación FISEVI
Outcome results
None listed