A Phase III, Multicentre, Double Blind, Placebo-Controlled, Randomised Clinical Trial of Apixaban THROMBOprophylaxiS TO Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,456
- 试验地点
- 1
- 主要终点
- 18.3.1.1 Objectively confirmed VTE
研究概览
简要总结
The aim of this trial is to find out if a tablet called apixaban can reduce blood clots in people with lung cancer having chemotherapy or similar treatments. Apixaban is a type of oral anticoagulant ("blood thinner") that makes the blood less sticky to prevent blood clots forming.
The trial is trying to find out if apixaban it can reduce blood clots in people with lung cancer.
Participants will receive the following treatment:
• Apixaban or placebo, 2.5mg taken by mouth twice a day for 6 months. This treatment will be taken in addition to any treatment that they are receiving to treat their lung cancer.
Participants will need to:
- Sign a consent form to enter the trial.
- Take the trial treatment as directed by the research team
- Complete a participant diary to record when they took the trial treatment
- Complete the Quality of Life and Health resource use questionnaires.
- Female participants of childbearing potential must use adequate contraception during the trial and for at least 2 days after trial treatment has finished.
详细描述
Venous thromboembolism (VTE) is common in lung cancer and results in worse quality of life, increased healthcare costs, increased morbidity, and mortality. VTE is also increased in lung cancer patients undergoing systemic anticancer therapy (SACT). VTE can be reduced using anticoagulation as thromboprophylaxis, but this is not the current standard of care for outpatients having SACT. The subcutaneous anticoagulant low molecular weight heparin can reduce VTE in lung cancer but can be inconvenient to take. Apixaban is a type of direct oral anticoagulant (DOAC) taken in tablet form and not requiring regular blood monitoring, which have a good safety profile and are licensed for other medical conditions. Whilst anticoagulants have been used for thromboprophylaxis in patients with cancer, the role of DOACs in ambulatory lung cancer patients is unanswered by the existing literature.
THROMBO-STOP is a multicentre, double blind, placebo-controlled, parallel group, two arm, phase 3 randomised clinical trial testing the efficacy of Apixaban to reduce VTE in ambulatory lung cancer patients undergoing SACT. There will be a process evaluation, acceptability study and economic evaluation. For this superiority trial, 1456 patients (728 per group) are required to have a 90% power of detecting, as significant with an alpha of 0.05 (two-sided), a decrease in the rate of VTE from 8.6% in the control group (placebo) to 4% in the intervention group (apixaban), assuming a 20% drop-out rate. The planned recruitment of 1456 patients would involve 34 sites.
THROMBO-STOP patients will be recruited over a 36-month period which includes a 12-month internal pilot among a projected 40% of sites.
Data from these elements inform our stop/go criteria. The pilot aims to i) assess recruitment rate and exclusions ii) to assess VTE event rate iii) to assess progression criteria.
The overall study time will be 60 months accounting for trial set up and analysis.
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)
盲法说明
Sponsor's clinical trial management team other than the trial statisticians
入排标准
- 年龄范围
- 16 Years 至 —（Child, 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
- 未提供
研究组 & 干预措施
Apixaban
apixaban 2.5 mg twice a day for 6 months
干预措施: Apixaban (Drug)
Placebo
apixaban matched placebo twice a day for 6 months
干预措施: Placebo (Other)
结局指标
主要结局
18.3.1.1 Objectively confirmed VTE
时间窗: 6 months
Difference between a composite of objectively confirmed VTE and VTE-related death in participants with lung cancer, commencing SACT or CRT, when treated with 6 months of apixaban vs. placebo.
次要结局
- Objectively confirmed VTE including all cause death(6 months)
- Bleeding outcomes(6 months)
- Net clinical benefit(6 months)
- Proximal or distal DVT (symptomatic or incidental)(6 months)
- Other rates of thrombosis(6 months)
- Survival outcomes(6 months)
- EQ-5D-5L questionnaire(6 months)
- VTE-related death(6 months)
- Global EORTC QLQ-C30 questionnaire(6 months)
- Time to VTE(6 months)
- Non-fatal PE(6 months)
- Lung cancer QLQ-LC29 questionnaire(6 months)