NCT04462003

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

June 29, 2020

Last Update Submit

July 3, 2020

Conditions

Deep Vein ThrombosisMalignancy

Outcome Measures

Primary Outcomes (3)

  • Recurrent deep venous thrombosis or venous thromboembolism

    New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism

    6 months

  • Occurrence of fatal or major bleeding

    Need for hospitalization, blood transfusion, surgical intervention or resulting into death

    6 months

  • Mortality related to massive pulmonary embolism

    Death caused by hemodynamic instability secondary to massive pulmonary embolism

    6 months

Secondary Outcomes (1)

  • Occurrence of non-fatal or minor bleeding

    6 months

Study Arms (2)

Apixaban

ACTIVE COMPARATOR

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

Enoxaparin

ACTIVE COMPARATOR

50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)

Drug: Enoxaparin

Interventions

ApixabanDRUG

10 mg/12 h for 1 week followed by 5 mg/12 h

Apixaban
EnoxaparinDRUG

1mg/Kg/sc/12h

Enoxaparin

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine,Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

RECRUITING

Related Publications (14)

  • 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.

    PMID: 10737280RESULT

  • 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.

    PMID: 30918939RESULT

  • 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.

    PMID: 10963635RESULT

  • 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 thrombosis. Blood. 2002 Nov 15;100(10):3484-8. doi: 10.1182/blood-2002-01-0108. Epub 2002 Jul 12.

    PMID: 12393647RESULT

  • 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;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.

    PMID: 26867832RESULT

  • 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.

    PMID: 31504429RESULT

  • 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/jth.13153. Epub 2015 Oct 29.

    PMID: 26407753RESULT

  • 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-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.

    PMID: 31630479RESULT

  • Agnelli G, Becattini C, Bauersachs R, Brenner B, Campanini M, Cohen A, Connors JM, Fontanella A, Gussoni G, Huisman MV, Lambert C, Meyer G, Munoz A, Abreu de Sousa J, Torbicki A, Verso M, Vescovo G; Caravaggio Study Investigators. Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study. Thromb Haemost. 2018 Sep;118(9):1668-1678. doi: 10.1055/s-0038-1668523. Epub 2018 Aug 13.

    PMID: 30103252RESULT

  • 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.

    PMID: 28373761RESULT

  • 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. No abstract available.

    PMID: 23702623RESULT

  • 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. No abstract available.

    PMID: 23725876RESULT

  • 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. No abstract available.

    PMID: 22898071RESULT

  • 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.

    PMID: 33153401DERIVED

MeSH Terms

Conditions

Venous ThrombosisNeoplasms

Interventions

apixabanEnoxaparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Mostafa E Mokadem

    Faculty of Medicine, Beni-Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa O Mokadem

CONTACT

00201009414408mostafa.elmokadem9@gmail.com

Abd el aziz Z Algaby

CONTACT

00201227563870zizogaby@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 8, 2020

Study Start

July 3, 2019

Primary Completion

July 2, 2020

Study Completion

July 3, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)