Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis

Deep Vein Thrombosis Clinical Trial

— DVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462003
• Other study ID #: Apixaban in DVT with cancer
• Status: Recruiting
• Phase: Phase 3
• Start date: July 3, 2019
• Est. completion date: July 3, 2020

Study information

• Verified date: July 2020
• Source: Beni-Suef University
• Contact: Mostafa O Mokadem
• Phone: 00201009414408
• Email: mostafa.elmokadem9[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 3, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Malignancy
• Neoplasms
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban
10 mg/12 h for 1 week followed by 5 mg/12 h
• Enoxaparin
1mg/Kg/sc/12h

Locations

Country	Name	City	State
Egypt	Faculty of Medicine,Beni-Suef University	Bani Suwayf	Beni-Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Agnelli G, Becattini C, Bauersachs R, Brenner B, Campanini M, Cohen A, Connors JM, Fontanella A, Gussoni G, Huisman MV, Lambert C, Meyer G, Muñoz A, Abreu de Sousa J, Torbicki A, Verso M, Vescovo G; Caravaggio Study Investigators. Apixaban versus Daltepar — View Citation

Agnelli G, Buller HR, Cohen A, Gallus AS, Lee TC, Pak R, Raskob GE, Weitz JI, Yamabe T. Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial. J Thromb Haemost. 2015 Dec;13(12):2187-91. doi: 10.1111/j — View 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. — View Citation

Cannon CP, Kohli P. Danger ahead: watch out for indirect comparisons! J Am Coll Cardiol. 2012 Aug 21;60(8):747-8. doi: 10.1016/j.jacc.2012.05.012. — View Citation

Cheung KS, Leung WK. Gastrointestinal bleeding in patients on novel oral anticoagulants: Risk, prevention and management. World J Gastroenterol. 2017 Mar 21;23(11):1954-1963. doi: 10.3748/wjg.v23.i11.1954. Review. — View Citation

Desai J, Granger CB, Weitz JI, Aisenberg J. Novel oral anticoagulants in gastroenterology practice. Gastrointest Endosc. 2013 Aug;78(2):227-39. doi: 10.1016/j.gie.2013.04.179. Epub 2013 May 29. Review. — View Citation

Desai J, Kolb JM, Weitz JI, Aisenberg J. Gastrointestinal bleeding with the new oral anticoagulants--defining the issues and the management strategies. Thromb Haemost. 2013 Aug;110(2):205-12. doi: 10.1160/TH13-02-0150. Epub 2013 May 23. Review. — View 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. — View Citation

Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Büller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retro — View Citation

Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb; — View Citation

Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jiménez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ní Áinle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Bell — View Citation

McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-ass — View Citation

Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, Marchiori A, Sabbion P, Prins MH, Noventa F, Girolami A. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous t — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent deep venous thrombosis or venous thromboembolism	New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism	6 months
Primary	Occurrence of fatal or major bleeding	Need for hospitalization, blood transfusion, surgical intervention or resulting into death	6 months
Primary	Mortality related to massive pulmonary embolism	Death caused by hemodynamic instability secondary to massive pulmonary embolism	6 months
Secondary	Occurrence of non-fatal or minor bleeding	Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death	6 months