NCT03289520已完成3 期
Effect of Clopidogrel on Early Failure of Arteriovenous Fistulas for Hemodialysis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)9 个研究点 分布在 1 个国家目标入组 877 人开始时间: 2003年1月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 877
- 试验地点
- 9
- 主要终点
- Fistula thrombosis (patency failure)
研究概览
简要总结
The objective of the study is to determine whether clopidogrel reduces the early failure rate of native AV fistulae. This study was originally registered as NCT00067119 which included two protocols, this one and the GRAFT study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-21 depending on state regulations
- •Life expectancy of at least six months
- •Chronic renal failure with anticipated start of hemodialysis within six months of enrollment, or current dialysis dependence
- •Planned creation of native upper extremity AV fistula
- •The patient is not on aspirin, or the patient is on aspirin but has not had a myocardial infarction or a cerebrovascular accident within the past 12 months.
- •The patient is expected to stay at a participating dialysis facility for at least 6 months.
- •The patient's physician(s) will allow the patient to participate.
- •Ability to give informed consent.
排除标准
- •Women must not be pregnant, breastfeeding, or plan to be pregnant during the course of the study.
- •The presence of ongoing bleeding.
- •The presence of a known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
- •Recent bleeding episode requiring transfusion within 12 weeks of entry.
- •The presence of acute ulcer disease. Acute ulcer disease is defined as a new diagnosis of peptic disease including esophagitis, gastritis, or ulcer or the initiation of treatment with proton pump inhibitors, H2 blockers or therapy for Helicobacter pylori within three months prior to obtaining consent.
- •A condition which prohibits discontinuation of anticoagulant drugs, aspirin, or nonsteroidal anti-inflammatory drugs during the six week study drug administration period. Use of heparin during dialysis is allowed.
- •Required use of oral or intravenous glucocorticoids at a dose greater than the equivalent of prednisone 15 mg per day during the six week study drug administration period.
- •Current unstable angina.
- •Required use of clopidogrel.
- •Known hypersensitivity to clopidogrel.
- •Medical considerations making anti-platelet therapy dangerous.
- •Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg at the time of enrollment.
- •Baseline platelet count less than 75,000/mm
- •Known advanced liver disease with decompensated cirrhosis, jaundice, ascites or bleeding varices.
- •Current problem with substance abuse.
- •Concurrent participation in another medical intervention trial.
- •Anticipated non-compliance with medical care based on physician judgment.
- •Patient refusal.
研究组 & 干预措施
Clopidogrel
Experimental
干预措施: Clopidogrel (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Fistula thrombosis (patency failure)
时间窗: 6 weeks
The fistula was classified as patent if a bruit was audible with a stethoscope throughout systole and diastole at least 8 cm proximal to the arteriovenous anastomosis. Fistula patency was assessed by trained study personnel.
次要结局
- Failure to attain suitability for dialysis (ability to use the fistula for dialysis with 2 needles and maintain a dialysis machine blood flow rate adequate for optimal dialysis (>=300 mL/min))(30 days)
研究者
研究点 (9)
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