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Anticoagulation for Atrial Fibrillation Post-Ablation (OCEAN Trial)
OCEAN Trial 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.
OCEAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOCEAN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OCEAN Trial Design
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Who is running the clinical trial?
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- 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.I had a successful heart rhythm correction procedure over a year ago with no arrhythmia since.I need long-term blood thinners for a condition that is not related to irregular heartbeats.I cannot or do not want to give permission for treatment.I am over 85 years old.I have not taken strong CYP3A affecting drugs in the last 4 days.I cannot take blood thinners due to a risk of bleeding.My kidney function is low, with a creatinine clearance under 30 mL/min.You have a certain score that shows your risk for stroke.I am older than 18 years.You have a health condition that makes it unsafe for you to have a magnetic resonance imaging (MRI) scan, or you are very afraid of being in small, enclosed spaces.I am a woman of childbearing age and I refuse to use effective birth control during the study.You have factors that increase your risk of having a stroke, but they are not related to atrial fibrillation.I had a severe stroke within the last year or any stroke in the past 14 days.I have a type of irregular heartbeat called valvular atrial fibrillation.I have atrial fibrillation not caused by heart valve issues.
- Group 1: Acetylsalicylic acid (ASA)
- Group 2: Rivaroxaban
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research endeavor an innovative approach?
"The first clinical trial of Acetylsalicylic acid (ASA) began in 2005, sponsored by Abbott and involving 15480. After this initial research was completed, the drug received its Phase 4 approval for use. Presently, there are 215 active trials ongoing worldwide with sites located across 60 countries and 1534 cities."
What is the aggregate quantity of participants in this medical trial?
"To effectively execute the research, 1572 candidates with the appropriate characteristics need to be identified. Bayer is funding and managing this project from many medical facilities including University of Ottawa Heart Institute in Ottawa, Ontario and St. Mary's General Hospital located in Kitchener, Quebec."
Has the Federal Drug Administration accepted Acetylsalicylic acid (ASA) as a viable medication?
"Power's team has assigned Acetylsalicylic acid (ASA) a score of 3 due to this being a Phase 4 trial, indicating the drug is approved and poses minimal risk."
How many healthcare facilities have been chosen to conduct this research endeavor?
"This trial is enlisting participants from across Canada, with focused recruitment at University of Ottawa Heart Institute in Ottawa, St. Mary's General Hospital in Kitchener, and Victoria Cardiac Arrhythmia Trials Inc. in Victoria as well as 21 additional sites."
What medical conditions might be alleviated through the use of Acetylsalicylic acid (ASA)?
"Acetylsalicylic acid is most often prescribed for pain relief, but has also proven beneficial in the treatment of myocardial infarction, catarrh, fractures and other bone-related issues."
Have researchers conducted any prior investigations into Acetylsalicylic acid (ASA)?
"Acetylsalicylic acid (ASA) was first investigated in 2005 by the Clinical Trial Service Unit, NDPH at the University of Oxford. Currently there are 712 completed clinical trials and 215 ongoing ones, many located within Ottawa's boundaries."
Are there still enrolment opportunities available in this clinical trial?
"Affirmative. According to the clinicaltrials.gov, this research trial is actively recruiting participants and was initially posted on 1st January 2016 with a recent edit occurring on 23rd March 2022. A total of 1572 patients need to be recruited from 21 distinct locations."
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