OCEAN
The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
STUDY DESIGN
Prospective, unblinded, randomised, controlled phase 4 study, international (Canada, China, Germany, Israel, Australia, Belgium), multicentre
Study objective
Study to investigate whether ongoing, long-term oral anticoagulation is superior to a treatment with antiplatelet therapy (ASA) alone in reducing the incidence of cerebral embolic events in moderate risk patients post successful catheter ablation for atrial fibrillation.
Description
Atrial fibrillation is an irregular heart rhythm in which the upper chambers of the heart (atria) beat very quickly. Atrial fibrillation can increase the risk of blood clots forming in the heart. These can detach and migrate to the brain, where they can trigger a stroke. Catheter ablation is a procedure that restores the normal heart rhythm. However, even patients who successfully undergo this treatment may have an increased risk of stroke compared to people who have never suffered from atrial fibrillation.
In order to reduce the risk of stroke, patients are prescribed one of two drugs after catheter ablation: a drug that inhibits platelet function (acetylsalicylic acid (ASA), e.g. Aspirin®), or a blood thinner (also known as an anticoagulant, e.g. rivaroxaban). The aim of this study is to find out which of these two types of treatment is best at preventing strokes.
CONTACT INFORMATION
Atul Verma, MD
Principal Investigator
Newmarket, Ontario
David Birnie, MD
Principal Investigator
Ottawa, Ontario
FURTHER INFORMATION
SPONSOR
Ottawa Heart Institute Research Corporation (OHIRC), Ottawa, Ontario, Kanada
AFNET ROLE
EU Sponsor Legal Representative, Regulatory Project Management for Germany