Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
REVERSE-AD
Reversal Effects of Idarucizumab on
Active Dabigatran
Outline
Background and Rationale
Objective
Methods
Results
Conclusion
Critical Appraisal Skills Programme (CASP)
Objective
Demonstrate efficacy of idarucizumab for reversal of
anticoagulant effect of Dabigatran
Assessment of bleeding and safety of idarucizumab
Methods
Multicenter study (>400 centers in 38
countries)
Open label, uncontrolled, prospective cohort
study
Interim study
Clinical study Phase 3
Study Eligibility
Inclusion criteria
Adults, 18 years or older, taking dabigatran
Presented in Emergency department
Exclusion criteria
Patients whose have dTT and ECT above
upper limit of normal range.
Study Design
Group A
Group B
Study Endpoints
Primary endpoint- maximum percentage of
reversal of anticoagulant effect of dabigatran
(measured by dilute thrombin time or ecarin
clotting time)
Secondary endpointProportion of patients who had complete
normalization of the dilute thrombin time or
ecarin clotting time in the first 4 hours and the
reduction in the concentration of unbound
dabigatran
Clinical outcomes as assessed by the physicians
Statistical Analysis
Cant tell
Results
Results
Results
Results
Results
Conclusion
Idarucizumab rapidly and completely
reversed the anticoagulant activity of
dabigatran in 88 to 98% of patients.
No safety concerns
Reference
1. Pollack CV, Reilly PA, Eikelboom J, Glund S,
Verhamme P, Bernstein R, et al. Idarucizumab
for Dabigatran Reversal. N Engl J Med
2015;373:511-20
2. Critical Apprasial Skills Programme, cohort
study checklist (2013)