Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism: The Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Proportion of patients screened who are eligible to participate in the trial
研究概览
简要总结
This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood thinners for the treatment of blood clots. Half of the patients will receive apixaban and half will receive rivaroxaban. The main objective is to determine the feasibility of patient recruitment and resources required to follow enrolled patients and inform for a larger, multi-centered trial and to assess which one is safer.
详细描述
Recently developed new oral anticoagulants (OAC) overcome some of the limitations of established therapy with vitamin K antagonists (VKA) and low molecular weight heparin (LMWH) for treatment of acute venous thromboembolism (VTE), due to ease of administration and more predictable pharmacokinetic properties. Many clinical questions about the new OAC remain unanswered because there have not been direct head-to-head comparison trials. For example, although studies have shown that rivaroxaban and apixaban are at least as effective and safe as LMWH and VKA, meta-analyses suggest that apixaban may be associated with lower bleeding risk. Concerns about the potential impact of medication non-adherence have been raised. Compliance with twice daily medications (e.g. apixaban) is often worse than once daily medications (e.g. rivaroxaban). Both of these medications are approved by Health Canada for treatment of VTE yet there is genuine uncertainty about which of the two direct OAC confer the best risk-to-benefit ratio.This is a multi-centre, prospective randomized open blinded end-point (PROBE) trial assessing clinical feasibility for a larger multi-centered trial comparing bleeding outcomes using apixaban vs. rivaroxaban for treatment of acute VTE. The primary objective of the study is to determine if it is feasible to conduct a large randomized multicenter trial comparing apixaban vs. rivaroxaban for the treatment of acute VTE. The secondary objectives are to assess safety and superiority of apixaban vs rivaroxaban.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed newly diagnosed acute VTE (proximal lower extremity deep vein thrombosis and segmental or greater pulmonary embolism)
- •Age ≥ 18 years old
- •Written informed consent
排除标准
- •Any contraindication for anticoagulation such as active bleeding
- •Clinically significant liver disease or alanine aminotransferase (ALT) levels ≥ 3 times the upper limit of normal range
- •Creatinine clearance < 30 ml/min calculated with the Cockcroft-Gault formula (29)
- •Known allergies to either apixaban or rivaroxaban
- •Pregnancy
- •Use of contraindicated medications with apixaban or rivaroxaban
- •Active malignancy in the last 6 months (excluding localized skin malignancy)
- •No private insurance coverage for the study drug or not willing to pay for study drug
研究组 & 干预措施
Apixaban
10 mg PO twice-a-day for 1 week, then 5 mg PO, twice daily for 3 or 6 months of treatment.
干预措施: Apixaban (Drug)
Rivaroxaban
15 mg PO twice-a-day for 3 weeks, then 20 mg PO once daily for 3 or 6 months of treatment.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Proportion of patients screened who are eligible to participate in the trial
时间窗: For the duration of the study 3-6 months
Assessing clinical feasibility for a larger multi-center trial - number of screened patients versus eligible patients
Proportion of eligible patients who consent to participate in the trial
时间窗: For the duration of the study 3-6 months
Assessing clinical feasibility for a larger multi-center trial - number of eligible patients versus patients who consent to participate
Proportion of patients who attend each follow-up visit
时间窗: For the duration of the study 3-6 months
Assessing clinical feasibility for a larger multi-center trial - number of patients that miss visits versus patients that attend visits.
Proportion of patients completing all required study procedures, per follow-up visit
时间窗: For the duration of the study 3-6 months
Assessing clinical feasibility for a larger multi-center trial - number of patients that complete all required procedures/study visits versus patients that do not.
次要结局
- Bleeding Events(For the duration of the study 3-6 months)
- Venous Thromboembolism(For the duration of the study 3-6 months)
- Death(For the duration of the study 3-6 months)
- Medication compliance(For the duration of the study 3-6 months)
- Time-to-event analysis(For the duration of the study 3-6 months)