NCT04462003

Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis

Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Deep Vein Thrombosis
• Malignancy

Interventions

Type	Name	Description
DRUG	Apixaban	10 mg/12 h for 1 week followed by 5 mg/12 h
DRUG	Enoxaparin	1mg/Kg/sc/12h

Timeline

• Start date: 2019-07-03
• Primary completion: 2020-07-02
• Completion: 2020-07-03
• First posted: 2020-07-08
• Last updated: 2020-07-08

Locations

1 site across 1 country: Egypt