The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance (EFFICIENT)
研究概览
详细说明
Aim:
Primary objective:
- To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI in patients with clopidogrel resistance
Secondary objective:
- To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI
- To evaluate the effect of continuing high dose clopidogrel treatment on bleeding complications after elective PCI
- To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit.
Study central:
Bursa Postgraduate Hospital, Cardiology Clinic
Study population:
we planned to enrol 180 patients. 50% of patients without clopidogrel resistance (control group: 90 patients) 50% have clopidogrel resistance. Than we randomise the patients (with clopidogrel resistance) in two groups (group 1:45 patients (75mg/day), group 2:45 patients (150mg/day))
inclusion criteria:
- The patients; who have planned elective PCI and have had written informed consent for participation to study.
- Age>18 year-old,
- The native coronary artery;lesion with narrowing >=70%
Exclusion criteria:
- Patients have allergy for ASA, Clopidogrel and heparin
- Patients who performed primary PCI
- Patients with acute coronary syndrome
- Patients with have a history of PCI and use clopidogrel
- Patients on warfarin therapy
- Patients who have bleeding diathesis, or have high risk for bleeding.
Study works:
- Write case report form for all patients
- Control for inclusion criteria.
- Evaluate the clopidogrel and ASA resistance with VerifyNow kit. Than randomised the patients.
- Demographic data (age, gender)
- Height, weight, BMI and GFR
- Risk factors
- laboratory data (biochemical and hematologic)
- Medication history
- Echocardiographic data
- Angiographic data
- PCI data(vessel diameter, stent diameter, lesion and stent length, performed PTCA or not, etc)
Note complication (MACE, bleeding, hematoma etc)
4 weeks later note the first control data and re assess the clopidogrel resistance with VerifyNow kit in patients groups 1 and 2.
Six months later note the second control data.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Bursa、火鸡、16320
- Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
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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:
- The patients; who have planned elective PCI and have had written informed consent for participation to study.
- Age>18 year-old,
- The native coronary artery;lesion with narrowing >=70%
Exclusion Criteria:
- Patients have allergy for ASA, Clopidogrel and heparin
- Patients who performed primary PCI
- Patients with acute coronary syndrome
- Patients with have a history of PCI and use clopidogrel
- Patients on warfarin therapy
- Patients who have bleeding diathesis, or have high risk for bleeding.
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 |
---|---|
实验性的:high dose clopidogrel
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high dose clopidogrel continuing after percutaneous coronary intervention
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths
大体时间:6 months.
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6 months.
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次要结果测量
结果测量 |
大体时间 |
---|---|
Major or minor bleeding according to TIMI criteria 30 days and 6 months To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit 30 days and 6 months.
大体时间:6 months
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6 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- Aleil B, Jacquemin L, De Poli F, Zaehringer M, Collet JP, Montalescot G, Cazenave JP, Dickele MC, Monassier JP, Gachet C. Clopidogrel 150 mg/day to overcome low responsiveness in patients undergoing elective percutaneous coronary intervention: results from the VASP-02 (Vasodilator-Stimulated Phosphoprotein-02) randomized study. JACC Cardiovasc Interv. 2008 Dec;1(6):631-8. doi: 10.1016/j.jcin.2008.09.004.
- Ari H, Ozkan H, Karacinar A, Ari S, Koca V, Bozat T. The EFFect of hIgh-dose ClopIdogrel treatmENT in patients with clopidogrel resistance (the EFFICIENT trial). Int J Cardiol. 2012 Jun 14;157(3):374-80. doi: 10.1016/j.ijcard.2010.12.083. Epub 2011 Jan 15.
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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