Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
研究概览
简要总结
This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in patients with cancer. The current standard treatment of venous thrombosis in cancer patients is subcutaneous injections with low molecular weight heparin. During the last 5 years several new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis. But very few cancer patients were included in the phase III clinical trials of the direct acting oral anticoagulants. Thus, there is a lack of information on how cancer patients with venous thrombosis will respond to treatment with direct acting oral anticoagulants. The current study will investigate the direct acting oral anticoagulant apixaban in cancer patients with venous thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •A diagnosis of cancer, other than basal-cell or squamous-cell carcinoma of the skin, within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer.
- •Objectively verified venous thrombosis
- •Informed consent
排除标准
- •Anticoagulant therapy prior to trial entry for > 96 hours
- •Severe thrombocytopenia (platelets <50·109/L)
- •Severe renal failure - creatinine clearance <30 ml/min
- •The patients will be treated with catheter based thrombolysis for deep venous thrombosis or systemic thrombolysis for severe pulmonary embolism
- •Pregnancy or breastfeeding.
- •Childbearing potential without proper contraceptive measures
- •Drug abuse or mental disease that may interfere with treatment and follow-up.
- •Severe malabsorption so that oral treatment are expected to have reduced effect
- •Mechanical heart valves
- •Known allergy to apixaban
- •Active bleeding or severe risk of bleeding so that the risk of bleeding is considered a greater danger than the risk of not treating the venous thrombosis
- •Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis)
- •Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole, voriconazole or posaconazole) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). Fluconazol is allowed.
研究组 & 干预措施
Apixaban
Apixaban 10 mg two times daily for 1 week, then apixaban 5mg two times daily for 6 months, then apixaban 2.5 mg two times daily for as long as the treating physician finds it necessary.
干预措施: Apixaban (Drug)
结局指标
主要结局
Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
时间窗: 6 months after inclusion
Major or clinically relevant non-major bleeding
时间窗: 6 months after inclusion
次要结局
- Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis(24 months after inclusion)
- Major or clinically relevant non-major bleeding(24 months after inclusion)
- All cause mortality(24 months after inclusion)
研究者
Anders Dahm
Senior Consultant, Associate Professor
University Hospital, Akershus