A Phase 3 interventional study of Apixaban and Enoxaparin in Deep Vein Thrombosis and Malignancy, sponsored by Beni-Suef University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by Beni-Suef University · Phase 3, Interventional, and Treatment
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.
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).
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Inclusion Criteria Patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy
Exclusion Criteria:
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
Drug: Apixaban
50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)
Drug: Enoxaparin
10 mg/12 h for 1 week followed by 5 mg/12 h
1mg/Kg/sc/12h
Recurrent deep venous thrombosis or venous thromboembolism
New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism
Time frame: 6 months
Occurrence of fatal or major bleeding
Need for hospitalization, blood transfusion, surgical intervention or resulting into death
Time frame: 6 months
Mortality related to massive pulmonary embolism
Death caused by hemodynamic instability secondary to massive pulmonary embolism
Time frame: 6 months
Occurrence of non-fatal or minor bleeding
Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death
Time frame: 6 months
Plan to share: No
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Beni-Suef University