Clinical trial NCT04462003: Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis
Official title: Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Malignancy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria Patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recurrent deep venous thrombosis or venous thromboembolism
timeFrame: 6 months
measure: Occurrence of fatal or major bleeding
timeFrame: 6 months
measure: Mortality related to massive pulmonary embolism
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of non-fatal or minor bleeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Faculty of Medicine,Beni-Suef University
state: Beni-Suef
Study officials:
affiliation: Faculty of Medicine, Beni-Suef University
name: Mostafa E Mokadem
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
citation: Ay C, Beyer-Westendorf J, Pabinger I. Treatment of cancer-associated venous thromboembolism in the age of direct oral anticoagulants. Ann Oncol. 2019 Jun 1;30(6):897-907. doi: 10.1093/annonc/mdz111.
citation: Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Buller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol. 2000 Sep;18(17):3078-83. doi: 10.1200/JCO.2000.18.17.3078.
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citation: Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
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citation: Mokadem ME, Hassan A, Algaby AZ. Efficacy and safety of apixaban in patients with active malignancy and acute deep venous thrombosis. Vascular. 2021 Oct;29(5):745-750. doi: 10.1177/1708538120971148. Epub 2020 Nov 5.