Anticoagulation for Atrial Fibrillation Post-Ablation
(OCEAN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments to prevent strokes in people with atrial fibrillation (AF) who have undergone a successful ablation procedure to correct their irregular heartbeat. The study compares a daily aspirin with a daily dose of the blood thinner Rivaroxaban (also known as Xarelto) to determine which is more effective. It is ideal for those who have been free of AF symptoms for over a year after ablation and have a stroke risk score related to their AF. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments benefit more patients, offering an opportunity to contribute to valuable insights.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've been on certain strong medications like CYP3A inducers or inhibitors within a few days of joining. It's best to discuss your current medications with the trial team.
What is the safety track record for these treatments?
Research has shown that aspirin, also known as acetylsalicylic acid (ASA), can be a safe option for many patients after a successful procedure to treat atrial fibrillation (AF). One study found that switching from warfarin to aspirin three months post-procedure can be as safe and effective as continuing long-term blood thinners for some patients.
Regarding rivaroxaban, studies indicate it is generally well-tolerated. The risk of stroke, blood vessel blockage, or death was similar for patients taking rivaroxaban compared to those on warfarin. Additionally, using rivaroxaban continuously around the time of the procedure appears to be as safe as other blood thinners.
Both aspirin and rivaroxaban have been studied and are considered safe options for patients after the procedure, with no major differences in serious side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they offer unique approaches to anticoagulation for patients with atrial fibrillation post-ablation. Unlike traditional anticoagulants like warfarin, which require regular blood monitoring and dietary restrictions, Rivaroxaban is a direct oral anticoagulant that provides a more convenient, once-daily dosing without the need for ongoing monitoring. Acetylsalicylic acid (ASA), commonly known as aspirin, is notable for its established safety profile and accessibility, offering an alternative for those who may be intolerant to other anticoagulant therapies. These options may provide patients with more flexibility and improve quality of life without compromising efficacy.
What evidence suggests that this trial's treatments could be effective for stroke prevention in atrial fibrillation patients post-ablation?
In this trial, participants will receive either acetylsalicylic acid (ASA) or rivaroxaban to manage stroke risk after atrial fibrillation (AF) ablation. Research has shown that aspirin, also known as ASA, can be helpful after AF ablation, with studies suggesting it can be as safe and effective as long-term blood thinners like warfarin for preventing strokes in some patients. Rivaroxaban is another option studied in this trial. Some studies found it effective in lowering the risk of stroke without increasing the chance of bleeding after AF ablation. Both aspirin and rivaroxaban have shown promise in managing stroke risk after successful AF ablation, but the best choice may depend on individual health needs and a doctor's advice.13567
Who Is on the Research Team?
Atul Verma, MD
Principal Investigator
Southlake Regional Health Centre
David H Birnie, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
This trial is for adults over 18 who've had successful catheter ablation for non-valvular atrial fibrillation at least a year ago, with no arrhythmia since then and have a CHA2DS2-VASc score of 1+. It's not for those with severe kidney issues, recent strokes, conditions needing long-term blood thinners other than AF, or women at risk of pregnancy not using contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either ASA 75-160 mg daily or rivaroxaban 15 mg daily for stroke prevention post-ablation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including annual blood tests, ECG, Holter monitoring, and quality of life assessments
MRI Assessment
Cerebral MRI scanning at baseline and at three years to assess for silent cerebral infarction
What Are the Treatments Tested in This Trial?
Interventions
- Acetylsalicylic acid
- Rivaroxaban
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor
Abbott
Industry Sponsor
Dr. Etahn Korngold
Abbott
Chief Medical Officer
MD, Harvard Medical School
Robert B. Ford
Abbott
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Biotronik Canada Inc
Industry Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator