Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg (IDASCOP 1)
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
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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Ben Arous、突尼斯
- HMPIT
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- Male or female aged between 18 to 75 years old.
- Proven ACS requiring PTCA within 1 week of inclusion. The ACS should be without ST-segment elevation (presence of chest pain with ST-segment or T-wave changes without sustained ST segment elevation) with elevation of cardiac biomarkers of MI (positive troponins).
- Coronary angiography showing at least one coronary lesion, whether mono, bi or multi-truncate
- Type 2 diabetes confirmed for at least one year
- Patient candidate for treatment with Clopidogrel
- Informed consent of patients
Non-Inclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
COPIGREL® - clopidogrel dosed at 75 mg per tablet
其他名称：
|
|
有源比较器：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.
|
COPIGREL® - clopidogrel dosed at 75 mg per tablet
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Major Cardiovascular Events (MACE)
大体时间：1 year after coronary intervention
|
Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis.
|
1 year after coronary intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Bleeding Events
大体时间：At 1, 3, 6, 9 and 12 months from patient enrollment
|
All bleeding events (digestive, cerebral, other locations)
|
At 1, 3, 6, 9 and 12 months from patient enrollment
|
|
Heart Failure Readmission
大体时间：At 1, 3, 6, 9 and 12 months from patient enrollment
|
Incidence of heart failure hospital readmissions
|
At 1, 3, 6, 9 and 12 months from patient enrollment
|
|
Global Death
大体时间：At 1, 3, 6, 9 and 12 months from patient enrollment
|
Incidence of death of all causes (death of cardiovascular origin and death of non-cardiovascular origin)
|
At 1, 3, 6, 9 and 12 months from patient enrollment
|
|
Incidence of Adverse Events
大体时间：At 1, 3, 6, 9 and 12 months from patient enrollment
|
Incidence of Adverse Events (AE) including Serious Adverse Events (SAE)
|
At 1, 3, 6, 9 and 12 months from patient enrollment
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.