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).
Publication types
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Clinical Trial, Phase III
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Multicenter Study
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Observational Study
MeSH terms
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Antibodies, Monoclonal, Humanized / adverse effects
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Antibodies, Monoclonal, Humanized / therapeutic use*
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Antithrombins / adverse effects
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Antithrombins / therapeutic use*
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Blood Coagulation / drug effects*
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Blood Coagulation Tests
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Blood Loss, Surgical / prevention & control*
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Clinical Protocols
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Coagulants / adverse effects
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Coagulants / therapeutic use*
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Dabigatran / adverse effects
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Dabigatran / therapeutic use*
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Hemorrhage / chemically induced
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Hemorrhage / diagnosis
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Hemorrhage / prevention & control*
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Humans
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Research Design
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Treatment Outcome
Substances
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Antibodies, Monoclonal, Humanized
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Antithrombins
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Coagulants
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idarucizumab
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Dabigatran
Associated data
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ClinicalTrials.gov/NCT02104947