Incidence Des évènements cArdiovasculaires majeurS Chez Les Patients COronariens diabétiques Subissant Une angioPlastie Coronaire et traités Par Clopidogrel à la Dose 150 mg Versus 75 mg
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Major Cardiovascular Events (MACE)
研究概览
简要总结
Acute Coronary Syndrome (ACS) is triggered by the rupture of an atherosclerotic plaque that results in a platelet aggregation reaction in the coronary artery. The administration of antiplatelet agents starting from the acute phase of the disease has helped reduce the risk of ischemic relapse both during initial and long-term hospitalization.
Management of clopidogrel following an ischemic event has been the subject of several treatment regimens ranging from a single continuous dose to a sequential double dose of between 7 and 30 days. The CURRENT-OASIS 7 therapeutic trial showed a benefit of clopidogrel double dose in reducing the risk of myocardial intervention (MI) and the composite outcome: cardiovascular mortality, MI, or stroke (CVA/TIA) at 30 days. However, the study protocol was interested in all ACSs, regardless of the Type 2 Diabetes Mellitus (T2DM) status in selected patients. Also, doubling of clopidogrel dose was maintained over 7 days after angioplasty. The literature describes an increased cardiovascular risk in type II diabetics in secondary prevention. No previous study has evaluated the effect of clopidogrel double dose given for 1 month on the reduction of this risk in the long-term in diabetic patients.
Thus, the objective of this study is to evaluate the efficacy and safety of clopidogrel double dose, given for 1 month in ACS in the diabetic patient.
详细描述
The study is an open label, multicentric clinical trial. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-consenting patient and/or participating in another clinical study
- •ACS with ST segment elevation (STEMI)
- •History of digestive or cerebral bleeding with antiplatelet agents or anticoagulants
- •Insulin-dependent diabetes mellitus (IDDM)
- •Diabetic requiring insulin
- •Patient in cardiogenic shock
- •Patient under treatment with anti-glycoprotein IIb/IIIa or stopped less than 72 hours prior to inclusion
- •Previously treated with clopidogrel or thrombolytics
- •Patients programmed for surgery in less than 6 months
- •Ischemic stroke less than 6 weeks old
- •History of haemorrhagic stroke (regardless of time)
- •Patients under or candidates for Vitamin K antagonist (VKA)
- •Patients under another antiplatelet agent (Ticlopidine, Prasugrel)
- •Patients with a contraindication to clopidogrel (hypersensitivity to the active substance or to any of the excipients, severe hepatic impairment, progressive hemorrhagic lesion such as peptic ulcer or intracranial hemorrhage)
- •Under omeprazole treatment, or considered during the study
- •Anemia (Hb <12g/dl)
- •Thrombocytopenia with less than 100000 cells/mm3
- •Serum creatinine greater than 200 μmol/l
- •Pregnancy and/or breast-feeding
- •Severe renal impairment
- •Exclusion criteria:
- •Non-compliance with treatment (treatment compliance <80%)
- •AE/SAE requiring cessation of treatment
- •Planning a CABG
- •Occurrence of pregnancy during the study
排除标准
- 未提供
研究组 & 干预措施
Arm 1 (single dose)
Will receive a clopidogrel loading dose of 600 mg PO, then a daily dose of clopidogrel 75 mg PO until the angioplasty is performed. After coronary intervention, a daily dose of clopidogrel 150 mg PO for 7 days will be given, followed by a daily single dose of clopidogrel (75 mg PO) for 21 days. Maintenance therapy will be clopidogrel daily dose of 75 mg PO thereafter, until the end of the study.
干预措施: Clopidogrel (Drug)
Arm 2 (double dose)
Will receive a clopidogrel loading dose of 600 mg PO, then a daily dose of clopidogrel 75 mg PO until the angioplasty is performed. After coronary intervention, a daily dose of clopidogrel 150 mg PO for 7 days will be given, followed by a daily double dose of clopidogrel (150 mg PO) for 21 days. Maintenance therapy will be clopidogrel daily dose of 75 mg PO thereafter, until the end of the study.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Major Cardiovascular Events (MACE)
时间窗: 1 year after coronary intervention
Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis.
次要结局
- Bleeding Events(At 1, 3, 6, 9 and 12 months from patient enrollment)
- Heart Failure Readmission(At 1, 3, 6, 9 and 12 months from patient enrollment)
- Global Death(At 1, 3, 6, 9 and 12 months from patient enrollment)
- Incidence of Adverse Events(At 1, 3, 6, 9 and 12 months from patient enrollment)