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

doi:10.1007/s11239-014-1064-7

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

Medicine

Résultat de recherche: Article › examen par les pairs

30 Citations (Scopus)

Résumé

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.

Langue d'origine	English
Pages (de-à)	485-492
Nombre de pages	8
Journal	Journal of Thrombosis and Thrombolysis
Volume	38
Numéro de publication	4
DOI	https://doi.org/10.1007/s11239-014-1064-7
Statut de publication	Published - oct. 2 2014

Note bibliographique

Funding Information:
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, Glaxo-SmithKline, 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 Ingel-heim, 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.

Publisher Copyright:
© 2014, Springer Science+Business Media New York.

ASJC Scopus Subject Areas

Hematology
Cardiology and Cardiovascular Medicine

PubMed: MeSH publication types

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Accès au document

10.1007/s11239-014-1064-7

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title = "Design of the rivaroxaban for heparin-induced thrombocytopenia study",

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.",

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note = "Funding Information: 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, Glaxo-SmithKline, 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 Ingel-heim, 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. Publisher Copyright: {\textcopyright} 2014, Springer Science+Business Media New York.",

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AU - Wells, Philip S.

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Design of the rivaroxaban for heparin-induced thrombocytopenia study

Résumé

Note bibliographique

ASJC Scopus Subject Areas

PubMed: MeSH publication types

Accès au document

Autres fichiers et liens

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