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Antiplatelet Agent

Anticoagulation for Atrial Fibrillation Post-Ablation (OCEAN Trial)

Phase 4
Waitlist Available
Led By Atul Verma, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be >18 years of age
Patient must have non-valvular AF
Must not have
Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent
Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include bleeding risks associated with both Rivaroxaban and Aspirin. Rivaroxaban may also cause digestive tract discomfort, dizziness, or headaches. Aspirin can lead to stomach ulcers or increase the chance of bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have atrial fibrillation not caused by heart valve issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take blood thinners or antiplatelet medications due to other health issues.
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I need long-term blood thinners for a condition that is not related to irregular heartbeats.
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I cannot or do not want to give permission for treatment.
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I am over 85 years old.
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I have not taken strong CYP3A affecting drugs in the last 4 days.
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I cannot take blood thinners due to a risk of bleeding.
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My kidney function is low, with a creatinine clearance under 30 mL/min.
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I am a woman of childbearing age and I refuse to use effective birth control during the study.
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I have a type of irregular heartbeat called valvular atrial fibrillation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI
Secondary study objectives
All-cause mortality
Clinical, overt stroke
Composite of all major and minor bleeding
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Acetylsalicylic acid (ASA)Active Control1 Intervention
ASA 75-160 mg daily (if intolerant to ASA, no antiplatelet therapy will be prescribed)
Group II: RivaroxabanActive Control1 Intervention
Rivaroxaban 15 mg daily

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,275 Previous Clinical Trials
25,538,115 Total Patients Enrolled
95 Trials studying Atrial Fibrillation
2,269,716 Patients Enrolled for Atrial Fibrillation
Biotronik Canada IncIndustry Sponsor
4 Previous Clinical Trials
588 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
188 Patients Enrolled for Atrial Fibrillation
Ottawa Heart Institute Research CorporationLead Sponsor
195 Previous Clinical Trials
92,216 Total Patients Enrolled
24 Trials studying Atrial Fibrillation
5,762 Patients Enrolled for Atrial Fibrillation

Media Library

Acetylsalicylic acid (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02168829 — Phase 4
Atrial Fibrillation Research Study Groups: Acetylsalicylic acid (ASA), Rivaroxaban
Atrial Fibrillation Clinical Trial 2023: Acetylsalicylic acid Highlights & Side Effects. Trial Name: NCT02168829 — Phase 4
Acetylsalicylic acid (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02168829 — Phase 4
~68 spots leftby Jul 2025
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