(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention) (REDUCED)
A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention
The hypothesis:
Low dose intracoronary unfractionated heparin is as effective and safe as standard dose intravenous unfractionated heparin on patients with elective percutaneous coronary intervention.
研究概览
详细说明
Aim:
Primary objective:To evaluate the efficiency and safety of low dose intracoronary unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI).
Secondary objective:
- To evaluate the effect of low dose intracoronary UFH on myocardial ischemia after PCI.
- To evaluate the effect of low dose intracoronary UFH on bleeding complications after PCI.
- To evaluate the cost-effectivity of low dose intracoronary UFH on elective PCI
Study central:
- Bursa Postgraduate Hospital, Cardiology Clinic
Study population:
- we planned to enrol 200 patients.
- Patients will randomise in two groups (control group:100 patients, study group:100 patients)
Study works:-Write case report form for all patients
- Control for inclusion criteria
- Demographic data (age, gender)
- Height, weight, BMI and glomerular filtration rate (GFR)
- Risk factors
- laboratory data (biochemical and hematologic)
- Medication history
- Echocardiographic data
- Angiographic data
- Procedure time
- PCI data(vessel diameter, stent diameter, lesion and stent length, performed percutaneous transluminal coronary angioplasty (PTCA) or not, etc)
- Before and after procedure (activated clotting time) ACT value
- Before and after procedure troponin I (TnI) and Creatine kinase MB (CKMB) levels
- Note complication (MACE, bleeding, hematoma etc)
Note femoral compression time.
4 weeks later note the first control data.
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.
The native coronary artery;
- lesion with narrowing >=70%,
- lesion without thrombus
- no left main coronary artery (LMCA) lesion
- no chronic total occlusion lesion
Exclusion Criteria:
- Patients have allergy for acetylsalicylic acid (ASA), Clopidogrel and heparin
- Patients who performed primary PCI
- Patients with acute coronary syndrome
- Patients with have a history of myocardial infarction (MI) for two weeks
- Patients who were use UFH or low molecular weight heparin (LMWH) for 24 hours
- 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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Low dose intracoronary heparin
Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin
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elective coronary intervention
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有源比较器:Standard treatment arm
Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin
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elective coronary intervention
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Major Adverse Cardiac Events
大体时间:30 days
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30 days
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Major Adverse Cardiac Event
大体时间:30 days
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30 days
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合作者和调查者
调查人员
- 研究主任:Hasan Arı, MD、Bursa Postgraduate Hospital
出版物和有用的链接
一般刊物
- Stabile E, Nammas W, Salemme L, Sorropago G, Cioppa A, Tesorio T, Ambrosini V, Campopiano E, Popusoi G, Biondi Zoccai G, Rubino P. The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention. J Am Coll Cardiol. 2008 Oct 14;52(16):1293-8. doi: 10.1016/j.jacc.2008.07.026.
- Ari H, Kivac E, Ari S, Emlek N, Cetinkaya S, Celiloglu N, Sarigul OY, Aydin C, Akkaya M, Koca V, Bozat T, Gurdogan M. The REDUCED (a RandomisED stUdy Comparing standard systemic anticoagulation thErapy to low Dose intracoronary anticoagulation therapy for elective percutaneous coronary intervention) trial. A novel pharmacologic regime for elective percutaneous coronary intervention. Acta Cardiol. 2014 Dec;69(6):619-27. doi: 10.1080/ac.69.6.1000004.
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
与本研究相关的术语
其他研究编号
- BYİEAH1
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coronary intervention的临床试验
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人