Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis
- Registration Number
- NCT04462003
- Lead Sponsor
- Beni-Suef University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apixaban 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 Enoxaparin Enoxaparin 50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)
- Primary Outcome Measures
Name Time Method Recurrent deep venous thrombosis or venous thromboembolism 6 months New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism
Occurrence of fatal or major bleeding 6 months Need for hospitalization, blood transfusion, surgical intervention or resulting into death
Mortality related to massive pulmonary embolism 6 months Death caused by hemodynamic instability secondary to massive pulmonary embolism
- Secondary Outcome Measures
Name Time Method Occurrence of non-fatal or minor bleeding 6 months Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death
Trial Locations
- Locations (1)
Faculty of Medicine,Beni-Suef University
🇪🇬Banī Suwayf, Beni-Suef, Egypt