OCEAN Trial

OCEAN Trial
The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial

This study is taking place at a number of sites across Canada, China and Europe. The study is being done in order to find out whether an antiplatelet or an anticoagulant works best for preventing strokes. My EP is one of the principal investigators. I’m considering taking part in this trial. If I’m accepted and decide to participate, I will be prescribed either low dose ASA (75-160 mg) or rivaroxaban (15 mg) to be taken once daily. Whether I get the ASA or the rivaroxaban will be decided randomly, and I will know which group I’m being assigned to. Participants will be followed for three years with various tests, including cerebral MRIs.

Given that I have a gut issue that I believe may have been triggered by taking ASA 325 mg daily for about 5 years during the early stages of my Afib journey, I would not want to be randomized to the ASA group. In this case, I am told that they would instead randomize rivaroxaban against taking nothing.

My questions:

1. Regarding rivaroxaban, from what I’ve read, the side effects appear to be no better or no worse than Eliquis. I’m wondering if anyone on this forum has any experience with the drug, or any other information that would be helpful.
2. And, secondly, if I was assigned to the “take nothing” group, what your thoughts on that might be. I would really like to be off any kind of anticoagulant, so getting assigned to this group is appealing.

My background:

• index ablation in August 2019; into Afib the next day with HR in the 140s and other complications requiring hospitalization; several unsuccessful ECVs; paroxysmal Afib until second ablation
• second ablation in February 2020 was successful
• remained in NSR until June when I went into Aflutter following dental implant surgery; ECV in July was successful and have remained in NSR since
• experienced intermittent ectopics for several weeks in the fall; none since
• currently, only Rx is Eliquis 5 mg b.i.d.
• was on bisoprolol following July ECV until early January when I stopped it with EP’s approval; since then my RHR has climbed up into the high 80s and low 90s mostly; previously it was in the high 60s and low 70s
• I’m a 77 y.o. female

Appreciate any feedback. Thanks.

More info on the trial: here and here

The decision should be based on your CHADS-Vasc score.

Being a 77-year old female, you must have a CHADS-Vasc score of at least 3 (2 for age, 1 for female), but the point for being female isn't usually counted, so let's assume you're at least a CHADS-Vasc 2. A score of 2 or higher makes you a moderate-high risk. So if you have any other issue that scores a point, that would makes you a 3, and now you're into high-risk territory. Have you ever had a trans-esophageal echocardiogram (TEE)? If so, did the report note aortic plaque? At your age, virtually everyone has some degree of aortic plaque, and that right there gives you another point, so you're probably at least a 3.

If you get randomized into the nothing group, I would not participate if I were you. If you get randomized into the Xarelto (rivoroxaban) group, I would. Xarelto and Eliquis are very comparable and many people here take one or the other, most without problems.

Thanks, Carey. I have no other risks beyond being female and over 75. TEE was done in Feb 2020 just before ablation. Report said "aortic value is trileaflet and minimally thickened." Does that make me a 3?

Good to know that Xarelto and Eliquis are comparable.

May I ask why you would not participate in the nothing group if it were you?

I have not yet been accepted for screening for the study. My Aflutter episode last June may disqualify me for now. I'm awaiting word on that.

Quote
Lorraine
May I ask why you would not participate in the nothing group if it were you?

In my opinion, because of a moderate risk CHADS-Vasc score, you should have some anticoagulation, not nothing,

Quote
GeorgeN
In my opinion, because of a moderate risk CHADS-Vasc score, you should have some anticoagulation, not nothing,

That right there.

You know, if you're main objective is to get off anticoagulants, and aspirin is off the table, I don't think participating in a clinical trial is going to get you anything. You're either going to be on a full dose of Xarelto or nothing, and we don't think nothing is a safe option.

Why not just talk to your EP and see about dropping your Eliquis to a half-dose? Or if you prefer a single dose per day, you could do a half-dose of Xarelto instead. You're not far from the age where the dosing guidelines say you should probably drop to a half dose anyway, so this isn't a radical idea.

Thanks Carey and George. What you say makes sense. So I've decided to not participate in the trial. And thanks for the suggestion about half-dosing, Carey. I will talk to my EP about that.