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.
authors.affiliation: Department of Medicine, McMaster University, 1280 Main Street West, Juravinski Hospital Site, Rm A3-74, Hamilton, ON, L8S 4K1, Canada, linkinla@mcmaster.ca.
authors.forename: Lori-Ann
authors.initials: LA
authors.lastname: Linkins
authors.forename: Theodore E
authors.initials: TE
authors.lastname: Warkentin
authors.forename: Menaka
authors.initials: M
authors.lastname: Pai
authors.forename: Sudeep
authors.initials: S
authors.lastname: Shivakumar
authors.forename: Rizwan A
authors.initials: RA
authors.lastname: Manji
authors.forename: Philip S
authors.initials: PS
authors.lastname: Wells
authors.forename: Mark A
authors.initials: MA
authors.lastname: Crowther
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects*; D015331:Cohort Studies; D065427:Factor Xa Inhibitors / Q000627:therapeutic use*; D006493:Heparin / Q000009:adverse effects*; D006801:Humans; D009025:Morpholines / Q000627:therapeutic use*; D011446:Prospective Studies; D012107:Research Design; D000069552:Rivaroxaban; D013876:Thiophenes / Q000627:therapeutic use*; D013921:Thrombocytopenia / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy*
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D006493:Heparin; D000069552:Rivaroxaban