EUCTR2012-000497-38-ES进行中（未招募）不适用
VERDI Study (VERifynow in Diabetes non-responsiveness: a study on switching from Clopidogrel to Prasugrel). A randomized, mono-center study comparing the treatment plan of a loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with a stent. - VERDI
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •1. Age <18 years or >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 <60 Kg.
- •11. Hemoglobin <10.5 g/dl, or Hematocrit <30%.
- •12. Severe left ventricular systolic dysfunction, EF <35%.
- •13. Renal insufficiency with creatinine levels >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.
研究者
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