The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bleeding Post Cardiac Surgery
- Indication for Anticoagulation
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
About 10% of patients undergoing cardiac surgery have a prior history of atrial fibrillation (AF). Additionally, in the early post-operative period after cardiac surgery, 30-60% of patients develop AF which is associated with a significantly higher risk of stroke, even when transient. Oral anticoagu...
About 10% of patients undergoing cardiac surgery have a prior history of atrial fibrillation (AF). Additionally, in the early post-operative period after cardiac surgery, 30-60% of patients develop AF which is associated with a significantly higher risk of stroke, even when transient. Oral anticoagulation (OAC) therapy is the preferred method of thromboembolic prevention in these patients. In the post-operative period, however, the balance of benefits and risks of OAC may differ and the most safe and effective OAC therapy in that patient population is uncertain. Until 2009, vitamin K antagonists were the only OAC agents available for patients with AF. Although effective, their use is limited by a narrow therapeutic index requiring frequent international normalized ratio (INR) measurements to ensure appropriate levels of anticoagulation. This key limitation leads to non-compliance and discontinuation. In the last decade, direct oral anticoagulants (DOACs) - inhibitors of factor Xa or thrombin- have become broadly used in patients with atrial fibrillation. Treatment with a DOAC in patients with AF has been demonstrated to yield similar rates of thromboembolism, and a lower risk of intracranial bleeding when compared to vitamin K antagonists during long-term follow-up. Moreover, DOACs are more convenient for both patients and clinicians. They have a rapid onset of effect, fixed dosage that obviates the need for regular monitoring, and few interactions with food and other medications The purpose of this study is to establish whether DOACs are as safe as VKAs in the first few weeks after heart surgery. The results of this study will impact the treatment of hundreds of thousands of patients in the world every year.
Tracking Information
- NCT #
- NCT04284839
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Emilie Belley-Cote, MD, MSc McMaster University