title: Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran.
abstract: Idarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERSal Effects of Idarucizumab in Patients on Active Dabigatran (RE-VERSE AD™) is a global phase 3 prospective cohort study aimed at investigating idarucizumab in dabigatran-treated patients who present with uncontrollable or life-threatening bleeding, and in those requiring urgent surgery or intervention. We describe the rationale for, and design of the trial (clinicaltrials.gov NCT02104947).
authors.affiliation: Charles V. Pollack Jr., Department of Emergency Medicine, Pennsylvania Hospital, University of Pennsylvania Health System, 800 Spruce St, Philadelphia, PA 19107, USA, Tel.: +1 215 8297549, Fax: +1 215 8298044, E-mail: cvpollack@gmail.com.
authors.forename: Charles V
authors.initials: CV
authors.lastname: Pollack
authors.forename: Paul A
authors.initials: PA
authors.lastname: Reilly
authors.forename: Richard
authors.initials: R
authors.lastname: Bernstein
authors.forename: Robert
authors.initials: R
authors.lastname: Dubiel
authors.forename: John
authors.initials: J
authors.lastname: Eikelboom
authors.forename: Stephan
authors.initials: S
authors.lastname: Glund
authors.forename: Menno V
authors.initials: MV
authors.lastname: Huisman
authors.forename: Elaine
authors.initials: E
authors.lastname: Hylek
authors.forename: Chak-Wah
authors.initials: CW
authors.lastname: Kam
authors.forename: Pieter W
authors.initials: PW
authors.lastname: Kamphuisen
authors.forename: Joerg
authors.initials: J
authors.lastname: Kreuzer
authors.forename: Jerrold H
authors.initials: JH
authors.lastname: Levy
authors.forename: Frank
authors.initials: F
authors.lastname: Sellke
authors.forename: Joachim
authors.initials: J
authors.lastname: Stangier
authors.forename: Thorsten
authors.initials: T
authors.lastname: Steiner
authors.forename: Bushi
authors.initials: B
authors.lastname: Wang
authors.forename: Jeffrey I
authors.initials: JI
authors.lastname: Weitz
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects*; D001780:Blood Coagulation Tests; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D002985:Clinical Protocols; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000069604:Dabigatran / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000991:Antithrombins; D003029:Coagulants; C000594745:idarucizumab; D000069604:Dabigatran