Apixaban and dalteparin in active malignancy associated venous thromboembolism: The ADAM VTE trial

Robert McBane, Charles Lawrence Loprinzi, Aneel Arjun Ashrani, Juliana Perez Botero, Roberto A.Leon Ferre, Stanislav Henkin, Charles J. Lenz, Jennifer Le-Rademacher, Waldemar E. Wysokinski

Research output: Contribution to journalArticle

39 Scopus citations

Abstract

Currently, low molecular weight heparin (LMWH) is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. The rationale and design of this investigator initiated Phase IV, multicenter, randomized, open label, superiority trial assessing the safety of apixaban versus dalteparin for cancer associated VTE is provided (ADAM-VTE; NCT02585713). The main aim of the ADAM-VTE trial is to test the hypothesis that apixaban is associated with a significantly lower rate of major bleeding compared to dalteparin in the treatment of cancer patients with acute VTE. The primary safety outcome is rate of major bleeding. Secondary efficacy objective is to assess the rates of recurrent VTE or arterial thromboembolism. Cancer patients with acute VTE (n=300) are randomized to receive apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) or dalteparin (200 IU/Kg daily for 30 days followed by 150 IU/kg daily thereafter) for 6 months. Stratification factors used for randomization include cancer stage and cancer specific risk of venous thromboembolism using the Khorana score. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium comprised of 90 oncology practices in the United States and Canada. Based on the hypothesis to be tested, we anticipate that these trial results will provide evidence supporting apixaban as an effective treatment of cancer associated VTE at lower rates of major bleeding compared to LMWH.

Original languageEnglish (US)
Pages (from-to)1-10
Number of pages10
JournalThrombosis and Haemostasis
Volume117
Issue number10
DOIs
StatePublished - 2017

Keywords

  • Apixaban
  • Cancer
  • Dalteparin
  • Venous thromboembolism

ASJC Scopus subject areas

  • Hematology

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