NCT01720108已完成3 期
Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty
David Anderson1 个研究点 分布在 1 个国家目标入组 3,426 人开始时间: 2013年2月24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
- 发起方
- 入组人数
- 3,426
- 试验地点
- 1
- 主要终点
- major or clinically relevant non-major bleeding
研究概览
简要总结
In this study the investigators want to look at whether using aspirin instead of rivaroxaban (after initial treatment with rivaroxaban) works as well at preventing blood clots while also reducing risk of bleeding and is more cost effective in patients who have either a total hip replacement or total knee replacement.
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
- •All patients undergoing elective total hip or knee arthroplasty at the participating institutions will be potentially eligible for this study
排除标准
- •Hip or lower limb fracture in the previous three months
- •Metastatic cancer
- •Life expectancy less than 6 months
- •History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
- •History of aspirin allergy, active peptic ulcer disease or gastritis that in judgment of investigator precludes use of aspirin
- •History of significant hepatic disease or any other condition that in the judgement of the investigator precludes the use of rivaroxaban
- •Creatinine clearance less than 30 ml per minute
- •Platelet count less than 100 x 109 /L
- •Need for long-term anticoagulation due to a preexisting co-morbid condition or due to the development of venous thromboembolism following surgery but prior to randomization
- •Did not or will not receive rivaroxaban post-operatively for VTE prophylaxis
- •Bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty
- •Major surgical procedure within the previous three months
- •Requirement for major surgery post arthroplasty within 90 day period
- •Chronic daily aspirin use with dose greater than 100 mg a day
- •Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period
- •Geographical inaccessibility for follow-up
- •Unwilling or unable to give consent
- •Previous participation in the study
- •Concomitant use with drugs that are strong inhibitors or inducers of both P-gp and CYP3A4
研究组 & 干预措施
rivaroxaban
Active Comparator
rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
干预措施: rivaroxaban and ASA (Drug)
ASA
Experimental
ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
干预措施: rivaroxaban and ASA (Drug)
结局指标
主要结局
major or clinically relevant non-major bleeding
时间窗: up to 4 years
symptomatic venous thromboembolism
时间窗: up to 4 years
次要结局
- survival(up to 4 years)
- myocardial infarction(up to 4 years)
- stroke(up to 4 years)
- wound infection(up to 4 years)
- cost-effectiveness(up to 4 years)
研究者
David Anderson
Head, Department of Medicine, CDHA
Nova Scotia Health Authority
研究点 (1)
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