A Randomized Study With Loading Dose of Prasugrel Opposed to the Standard Dose of Clopidogrel in Type 2 Diabetic Patients in Acute Coronary Syndrome, Revascularized Through Drug-eluting Stent.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of patients who achieve inhibition of platelet aggregation greater that 50%
研究概览
简要总结
The purpose of this study is 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.
详细描述
The VERDI study consists on 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. The aim of this study is 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Clopidogrel
This group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg.
干预措施: Clopidogrel (Drug)
Prasugrel
This group will receive after PCI a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by a daily dose of prasugrel (10 mg tablet).
干预措施: Prasugrel. (Drug)
结局指标
主要结局
Number of patients who achieve inhibition of platelet aggregation greater that 50%
时间窗: 24 to 36 hours post-PCI
The principal objective is to determine whether in type 2 diabetic patients who are non-responsive to clopidogrel at habitual doses and who receive treatment through percutaneous coronary intervention (PCI) with a stent, a treatment plan with a loading dose of prasugrel (60 mg) followed by 1 cp (10 mg) once a day, is superior to a standard dose of 75 mg clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(30 days)
- Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.(30 days.)
- Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy(30 days.)