Grant: Project Grant
Ottawa Hospital Research Institute
$2,210,850.00
Comparison of Bleeding Risk between Rivaroxaban and Apixaban in Atrial Fibrillation (COBRRA AF)
FY 2021-22
Summary
Lay Abstract:
The direct oral anticoagulants (DOACs) apixaban and rivaroxaban have been compared to standard therapy for stroke prevention in atrial fibrillation (SPAF) in randomized controlled trials (RCT) and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these anticoagulants. Increased use of DOACs, limitations of Phase 3 trials, patient concerns, and litigation over bleeding events highlight the need for a comparison trial. The overall aim of this RCT is to compare the safety of 12 months duration of apixaban twice daily to rivaroxaban once daily in patients with non-valvular atrial fibrillation (AF). Patients will be monitored for the primary outcome of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) events during follow up. This trial will directly inform clinical practice and possibly lead to change in first line therapy.
Department
Program
Project Grant
Recipient
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database
As published
Id
450705
Name
Castellucci Lana
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
Comparison of Bleeding Risk between Rivaroxaban and Apixaban in Atrial Fibrillation (COBRRA AF)
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$2,210,850
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Atrial Fibrillation, Bleeding, Anticoagulation
Abstract
Lay Abstract:
The direct oral anticoagulants (DOACs) apixaban and rivaroxaban have been compared to standard therapy for stroke prevention in atrial fibrillation (SPAF) in randomized controlled trials (RCT) and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these anticoagulants. Increased use of DOACs, limitations of Phase 3 trials, patient concerns, and litigation over bleeding events highlight the need for a comparison trial. The overall aim of this RCT is to compare the safety of 12 months duration of apixaban twice daily to rivaroxaban once daily in patients with non-valvular atrial fibrillation (AF). Patients will be monitored for the primary outcome of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) events during follow up. This trial will directly inform clinical practice and possibly lead to change in first line therapy.
Competitiondate
202109
Approvedterm2
5 yrs 0 mth
Pinamesdelim
Castellucci, Lana; de Wit, Kerstin; Le Gal, Grégoire; Parkash, Ratika
Approvedterm
5 ans 0 mois
Cihrcontribution2
~ $2,210,850~ $0~