Journal of Thrombosis and Thrombolysis

, Volume 38, Issue 4, pp 485–492 | Cite as

Design of the rivaroxaban for heparin-induced thrombocytopenia study

  • Lori-Ann Linkins
  • Theodore E. Warkentin
  • Menaka Pai
  • Sudeep Shivakumar
  • Rizwan A. Manji
  • Philip S. Wells
  • Mark A. Crowther
Article

Abstract

Rivaroxaban is an ideal potential candidate for treatment of heparin-induced thrombocytopenia (HIT) because it is administered orally by fixed dosing, requires no laboratory monitoring and is effective in the treatment of venous and arterial thromboembolism in other settings. The Rivaroxaban for HIT study is a prospective, multicentre, single-arm, cohort study evaluating the incidence of new symptomatic venous and arterial thromboembolism in patients with suspected or confirmed HIT who are treated with rivaroxaban. Methodological challenges faced in the design of this study include heterogeneity of the patient population, differences in the baseline risk of thrombosis and bleeding dependent on whether HIT is confirmed or just suspected, and heterogeneity in laboratory confirmation of HIT. The rationale for how these challenges were addressed and the final design of the Rivaroxaban for HIT study is reviewed.

Keywords

Heparin-induced thrombocytopenia Rivaroxaban Study design Clinical trial 

Notes

Conflict of interest

All authors have contributed to the drafting of this manuscript. The Rivaroxaban for HIT Study is funded by an investigator-initiated study Grant from Bayer Inc. In the past 5 years, Dr. Linkins has received honoraria for presentations from Pfizer. Dr. Warkentin has received lecture honoraria from Pfizer Canada and Instrumentation Laboratories, has provided consulting services to, and/or has received research funding from, GlaxoSmithKline, W. L. Gore, Immucor GTI Diagnostics, and Paringenix, and has provided expert witness testimony relating to HIT. In the last 5 years, Dr. Wells has received honoraria for presentations from Bayer Healthcare, Boehringer Ingelheim, Pfizer and Biomerieiux. He is the recipient of an investigator-initiated research Grant from Bristol Myers Squibb/Pfizer. Dr. Shivakumar has received lecture honoraria from Bayer Inc. Dr. Crowther discloses having sat on advisory boards for Leo Pharma, Pfizer, Bayer, Boehringer Ingelheim, Alexion, CSL Behring, Portola, Viropharm and AKP America; provided expert testimony for Bayer and Merck and has received research funding from Boehringer Ingelheim, Octapharm, Pfizer and Leo Pharma. Dr. Manji and Dr. Pai have no conflict of interest with this study.

Supplementary material

11239_2014_1064_MOESM1_ESM.docx (13 kb)
Supplementary material 1 (DOCX 13 kb)

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Lori-Ann Linkins
    • 1
  • Theodore E. Warkentin
    • 7
    • 2
  • Menaka Pai
    • 7
    • 2
    • 3
  • Sudeep Shivakumar
    • 4
  • Rizwan A. Manji
    • 5
  • Philip S. Wells
    • 6
  • Mark A. Crowther
    • 7
    • 2
  1. 1.Department of MedicineMcMaster UniversityHamiltonCanada
  2. 2.Department of Pathology and Molecular MedicineMcMaster UniversityHamiltonCanada
  3. 3.Hamilton Regional Laboratory Medicine ProgramMcMaster UniversityHamiltonCanada
  4. 4.Department of MedicineDalhousie UniversityHalifaxCanada
  5. 5.Cardiac Sciences Program, Department of SurgeryUniversity of ManitobaWinnipegCanada
  6. 6.Department of Medicine, Ottawa Hospital Research InstituteUniversity of OttawaOttawaCanada
  7. 7.Department of MedicineMcMaster UniversityHamiltonCanada

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