Anticoagulation for Atrial Fibrillation Post-Ablation

(OCEAN Trial)

Recruiting at 54 trial locations

Overseen By David H Birnie, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Heart Institute Research Corporation

Must be taking: Blood thinners

Must not be taking: CYP3A inducers, CYP3A inhibitors

Disqualifiers: Stroke, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3 years

1284 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is comparing medical approaches for stroke prevention in people who have atrial fibrillation (AF) and have undergone a successful procedure called ablation to eliminate or substantially reduce the arrhythmia. AF is normally associated with an increased risk of stroke which in many patients can be prevented with appropriate blood thinner therapy. This trial will compare a strategy of oral anticoagulant therapy after successful ablation to therapy with an aspirin per day.

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 data supports the effectiveness of the drug combination of Acetylsalicylic acid, Rivaroxaban, and Xarelto for atrial fibrillation post-ablation?

Research shows that Rivaroxaban, when used with aspirin, provides better outcomes in preventing recurrent cardiovascular issues compared to aspirin alone. Additionally, Rivaroxaban has been effectively used in patients undergoing catheter ablation for atrial fibrillation, suggesting its potential benefit in similar settings. ^{1 2 3 4 5}

Is rivaroxaban safe for use in humans, especially after atrial fibrillation ablation?

Studies show that rivaroxaban is generally safe for use in humans, including during and after atrial fibrillation ablation procedures. It has been used safely in various conditions, with research indicating its safety in real-world settings and during specific medical procedures. ^{1 3 4 6 7}

How does the drug combination of Acetylsalicylic acid and Rivaroxaban differ from other treatments for atrial fibrillation post-ablation?

This drug combination is unique because it uses Rivaroxaban, a newer type of anticoagulant that selectively inhibits factor Xa (a protein involved in blood clotting), alongside Acetylsalicylic acid (aspirin), which is not typically used in standard anticoagulation therapy for atrial fibrillation post-ablation. This approach may offer a different mechanism of action compared to traditional treatments like vitamin K antagonists. ^{2 3 4 5 8}

Research Team

Atul Verma, MD

Principal Investigator

Southlake Regional Health Centre

David H Birnie, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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

I had a successful heart rhythm correction procedure over a year ago with no arrhythmia since.

You have a certain score that shows your risk for stroke.

I am older than 18 years.

Exclusion Criteria

You are very sick or are not expected to live for more than 3 years.

I cannot take blood thinners or antiplatelet medications due to other health issues.

I cannot have a loop recorder implanted due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 months

1 visit (in-person)

Treatment

Participants are randomized to receive either ASA 75-160 mg daily or rivaroxaban 15 mg daily for stroke prevention post-ablation

3 years

Annual visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including annual blood tests, ECG, Holter monitoring, and quality of life assessments

3 years

Annual visits (in-person)

MRI Assessment

Cerebral MRI scanning at baseline and at three years to assess for silent cerebral infarction

3 years

2 visits (in-person)

Treatment Details

Interventions

• Acetylsalicylic acid
• Rivaroxaban

Trial Overview The study compares two stroke prevention strategies in post-ablation AF patients: taking the oral anticoagulant Rivaroxaban versus daily Aspirin. The goal is to determine which approach is more effective after the elimination of arrhythmia through ablation.

Participant Groups

Group I: Acetylsalicylic acid (ASA) Active Control 1 Intervention

ASA 75-160 mg daily (if intolerant to ASA, no antiplatelet therapy will be prescribed)

Group II: Rivaroxaban Active Control 1 Intervention

Rivaroxaban 15 mg daily

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

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

Trials

5

Recruited

1,900+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Rivaroxaban combined with aspirin is more effective in preventing recurrent cardiovascular events than aspirin alone, with an incremental cost-effectiveness ratio (ICER) of €16,522 per quality-adjusted life-year (QALY) gained, based on a lifetime analysis of patients with coronary artery disease (CAD) or peripheral artery disease (PAD).

The cost-effectiveness of the combination therapy was consistent across subgroups, showing ICERs of €8003 for PAD and €18,599 for CAD, indicating that this treatment strategy is economically viable for improving cardiovascular outcomes in these patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy. Ferrara, P., Cortesi, PA., Di Laura, D., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of co-administration of amiodarone and rivaroxaban to co-administration of dronedarone and rivaroxaban for hemorrhage risks after atrial fibrillation ablation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes after catheter ablation and cardioversion in patients with non-valvular atrial fibrillation: results from the prospective, observational XANTUS study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Rivaroxaban for the prevention of venous thromboembolism after radiofrequency ablation of saphenous veins concomitant with miniphlebectomy, sclerotherapy, or no treatment of varicose tributaries. [2021]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[New ral nticoagulants During Catheter Ablation of Atrial Fibrillation. Experience With Rivaroxaban]. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. [2022]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[New Oral Anticoagulants During Catheter Ablation of Atrial Fibrillation. Experience With Rivaroxaban]. [2017]