Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,429
- 试验地点
- 2
- 主要终点
- Venous thromboembolism
研究概览
简要总结
Consented patients undergoing elective total hip and total knee arthroplasty will be randomized to receive either aspirin alone or aspirin and rivaroxaban for prevention of venous thromboembolism.
详细描述
Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone.
This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
over-encapsulated rivaroxaban/ASA
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
- •Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study
- •Written informed consent in accordance with federal, local and institutional guidelines
排除标准
- •Previous documented VTE (proximal DVT or any PE)
- •Hip or lower limb fracture in the previous three months, not related to present surgery
- •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 the judgment of investigator precludes use of aspirin
- •History of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban
- •Creatinine clearance less than 15 ml per minute
- •Pre-operative platelet count less than 100 x 109 /L
- •Need for long-term anticoagulation due to a pre-existing co-morbid condition or due to the development of VTE following surgery but prior to randomization
- •Received anticoagulation post operatively
- •Bilateral THA/TKA or simultaneous hip and knee arthroplasty
- •Major surgical procedure within the previous 3 months
- •Requirement for major surgery post arthroplasty within a 90 day period
- •Chronic daily aspirin use with dose greater than 100 mg a day
- •Women of childbearing potential who are not abstinent or do not use effective contraception or are breast-feeding throughout the study drug period
- •Unwilling or unable to give consent
- •Previous participation in the EPCAT III study
- •Under 18 years of age
- •Concomitant use of drugs that are strong inhibitors of P-gp AND CYP3A4 (e.g., systemic treatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of P-gp AND CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort)
- •Known allergy to food dye
研究组 & 干预措施
TKA-control arm
Total Knee Arthroplasty: 5 days of rivaroxaban, followed by 9 days of aspirin
干预措施: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg (Drug)
THA-control arm
Total Hip Arthroplasty: 5 days of rivaroxaban, followed by 30 days of aspirin
干预措施: Rivaroxaban 10 MG and acetylsalicylic acid 81 mg (Drug)
THA-study arm
Total Hip Arthroplasty: 35 days of aspirin
干预措施: acetylsalicylic acid 81 mg (Drug)
TKA-study arm
Total Knee Arthroplasty: 14 days of aspirin
干预措施: acetylsalicylic acid 81 mg (Drug)
结局指标
主要结局
Venous thromboembolism
时间窗: 90 days
symptomatic proximal deep vein thrombosis or pulmonary embolism
Bleeding
时间窗: 90 days
major and clinically relevant, non-major bleeds
次要结局
- Survival(90 days)
- Cost-effectiveness(90 days)
研究者
Sudeep Shivakumar
Head, Division of Hematology
Nova Scotia Health Authority