The Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 12, 2022

Primary Completion Date

May 30, 2024

Study Completion Date

May 30, 2024

Conditions
Atrial Fibrillation
Interventions
DRUG

Non-vitamin K oral anticoagulants (NOACs)

"NOAC Group (Intervention):~Patients randomized to the NOAC group will receive a NOAC dosed according to the Canadian monograph for the respective indication. Patients receiving a NOAC before cardiac surgery will resume the same NOAC as pre-operatively, whereas patients not previously receiving a NOAC will preferentially receive apixaban according to local practice. The NOAC will be started no earlier than post-operative day 5 and based on the standard protocol depending on whether the patient has a pre-existing indication for anticoagulation or new indication (e.g. post-operative atrial fibrillation).~Patients at high risk of thrombosis and low risk of bleeding will receive a standardized bridging protocol as early as post-operative day 3 with unfractionated heparin infusion or low molecular weight heparin until the NOAC is initiated."

DRUG

Warfarin

"Warfarin Group (Comparator):~Patients randomized to the warfarin group will receive warfarin titrated to achieve a target International Normalized Ratio (INR) of 2.5 (range 2.0 to 3.0). Warfarin will be started as early as post-operative day 1 and based on the standard protocol depending on whether the patient has a pre-existing indication for anticoagulation or new indication (e.g. post-operative atrial fibrillation).~Patients at high risk of thrombosis and low risk of bleeding will receive a standardized bridging protocol as early as post-operative day 3 with unfractionated heparin infusion or low molecular weight heparin until INR is 2.0 or above."

Trial Locations (1)

V6Z 1Y6

St. Paul's Hospital, Vancouver

All Listed Sponsors
lead

St. Paul's Hospital, Canada

OTHER