NCT00067119已完成3 期
Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
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 649 人开始时间: 2003年1月1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
- 649
- 试验地点
- 9
研究概览
简要总结
The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials.
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
- 未提供
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.
- •Known allergy or adverse reaction to Aggrenox or any of its study components (dipyridamole and aspirin).
- •Required use of warfarin, dipyridamole, non-steroidal antiinflammatory drugs or other antiplatelet agents other than aspirin.
- •Current uncontrolled hypertension with systolic blood pressure in excess of 200 mm Hg or diastolic blood pressure in excess of 115 mm Hg.
- •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
Aggrenox
Experimental
干预措施: Aggrenox (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
研究者
研究点 (9)
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