Apixaban and dalteparin in active malignancy associated venous thromboembolism

Robert McBane II; Charles L. Loprinzi; Aneel Ashrani; Juliana Perez Botero; Roberto A. Leon Ferre; Stanislav Henkin; Charles J. Lenz; Jennifer G. Le-Rademacher; Waldemar E. Wysokinski

doi:10.1160/TH17-03-0193

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2017; 117(10): 1952-1961
DOI: 10.1160/TH17-03-0193

Trial Protocol Design Paper

Schattauer GmbH

Apixaban and dalteparin in active malignancy associated venous thromboembolism

The ADAM VTE Trial

Robert McBane II

¹Mayo Clinic, Rochester, Minnesota, USA

,

Charles L. Loprinzi

¹Mayo Clinic, Rochester, Minnesota, USA

,

Aneel Ashrani

¹Mayo Clinic, Rochester, Minnesota, USA

,

Juliana Perez Botero

¹Mayo Clinic, Rochester, Minnesota, USA

,

Roberto A. Leon Ferre

¹Mayo Clinic, Rochester, Minnesota, USA

,

Stanislav Henkin

¹Mayo Clinic, Rochester, Minnesota, USA

,

Charles J. Lenz

¹Mayo Clinic, Rochester, Minnesota, USA

,

Jennifer G. Le-Rademacher

¹Mayo Clinic, Rochester, Minnesota, USA

,

Waldemar E. Wysokinski

¹Mayo Clinic, Rochester, Minnesota, USA

› Author Affiliations

Abstract

Summary

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.

Key words

Cancer - venous thromboembolism - apixaban - dalteparin

Full Text

References

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