Recruitment

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