Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recurrent deep venous thrombosis or venous thromboembolism
研究概览
简要总结
The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). It was hypothesised that Apixaban could be as effective as rivaroxiban and edoxaban in treatment of patients with acute DVT and active malignancy with a lower risk of bleeding especially in those with GIT cancer.
详细描述
Patients with active malignancy have hypercoagulable state particularly, those receiving intravenous chemotherapy, with six fold higher risk of venous thromboembolism (VTE) [1]. Anticoagulation for malignancy associated deep venous thrombosis (DVT) can be difficult because of different limitations like bleeding, drug-drug interactions with chemotherapy and inconvenience with repeated subcutaneous injections of low-molecular-weight heparin (LMWH) [2]. In comparison with patients without active malignancy, patients with cancer who are on warfarin therapy have 2 to 6 folds more major bleeding events and 2 to 3 times more VTE recurrence [3,4]. The American College of Chest Physicians Guidelines recommended (LMWH) as standard therapy for management of acute VTE in patients with active malignancy [5]. Recently, Rivaroxiban and Edoxaban were considered as an alternative to weight-adjusted subcutaneous LMWH after pulmonary embolism in patients with active cancer without gastrointestinal (GIT) malignancy [6]. Apixaban is a direct factor Xa inhibitor approved by FDA for treatment of DVT and VTE [7]. However its efficacy in management of acute DVT and VTE associated with cancer is still unresolved issue. The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH).
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
- Single (Participant)
盲法说明
Single blind
入排标准
- 年龄范围
- 20 Years 至 80 Years（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
- •Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy
- •Previous DVT or venous thromboembolism
- •Administration of LMWH or unfractionated heparin before randomization
- •Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)
- •Thrombocytopenia (platelets <100 x 109L)
- •Severe chronic kidney disease (estimated glomerular filtration rate <30 ml/minute)
- •Pregnant women
研究组 & 干预措施
Apixaban
50 patients with DVT with malignancy were randomized to apixaban 10 mg twice daily dose for 7 days followed by apixaban 5 mg twice daily
干预措施: Apixaban (Drug)
Enoxaparin
50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Recurrent deep venous thrombosis or venous thromboembolism
时间窗: 6 months
New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism
Occurrence of fatal or major bleeding
时间窗: 6 months
Need for hospitalization, blood transfusion, surgical intervention or resulting into death
Mortality related to massive pulmonary embolism
时间窗: 6 months
Death caused by hemodynamic instability secondary to massive pulmonary embolism
次要结局
- Occurrence of non-fatal or minor bleeding(6 months)
研究者
Mostafa El Mokadem
Dr
Beni-Suef University