ELIQUIS trial for On-X valve patients

[Keithl]

So Cleveland Clinic called me today to ask if I was interested in joining the trial for Eliquis vs. Warfarin. I spent time talking to them about the trial and such and told them my concerns. I mentioned I was less than impressed with the On-X sampling to get 1.5-2.0 INR approved so was curious how many people in this study. She did not know, but said she would try and find out. They prescribe does based on age and kidney function, for me would typically be 5mg 2x daily. Entering the trial gives you 50/50 chance of being selected for Eliquis or to be the baseline warfarin user. I chatted for a while with the person stating that warfarin has decades of proven history with all the know pros and cons. I signed up, but more to hope for the warfarin side and will likely decline if I am chosen for the Eliquis side. With no way to measure the effectiveness what it is doing or not I prefer the old school method.

 

[pellicle]

Good morning, all sounds interesting. Personally I have reservations about "one size fits all" and how well it actually controls anti-coagulation since it can't be tuned.

I hope it goes well for you, the proof of the pudding however will of course be after the trial has completed, use is granted and we start to see more users of the drug out there and can get actual reported data.

Myself I doubt (lets assume it is approved) I'll move there because simply the costs of it VS warfarin and testing are higher than I want to spend and I prefer knowing what my balance is.

I note that the primary selling point is to dwell on the "no testing required" but personally I don't see that as a bonus. I believe that its well documented that testing increases awareness of taking and feeds back into "drug compliance" ... the other one about "no restrictions on diet" is pretty minor also (exceptions being things like grapefruit).

I'll follow this with interest.

 

[tom in MO]

So Cleveland Clinic called me today to ask if I was interested in joining the trial for Eliquis vs. Warfarin. I spent time talking to them about the trial and such and told them my concerns. I mentioned I was less than impressed with the On-X sampling to get 1.5-2.0 INR approved so was curious how many people in this study. She did not know, but said she would try and find out. They prescribe does based on age and kidney function, for me would typically be 5mg 2x daily. Entering the trial gives you 50/50 chance of being selected for Eliquis or to be the baseline warfarin user. I chatted for a while with the person stating that warfarin has decades of proven history with all the know pros and cons. I signed up, but more to hope for the warfarin side and will likely decline if I am chosen for the Eliquis side. With no way to measure the effectiveness what it is doing or not I prefer the old school method.

They won't tell you which drug you are receiving if it is a blinded study. I'd ask her if they cover expenses if you are on the Eliquis side and have a stroke.

 

[Keithl]

It is not a blind study since they need to monitor INR if you are on the warfarin side of the study.

 

[vitdoc]

They would probably have everyone get blood tests for INR to avoid letting patients know what they are on. The patients would not be privy to the info. Not sure how they would mask changing warfarin dosing. Personally I would not sign up for this. Not interested in having a stoke. Don’t see any gain for anyone in the study.

 

[Keithl]

Nope, they told me if I was selected for Eliquis I just take the pills and have to talk to them every month and get periodic blood work.

 

[user 15848]

IF proper study of such matter ever exist, i for sure would consider switching from W to E, since know many people who had strokes using E, BUT, i will not participate in an study to get this done since risks are too high, Warfarin works regardless of afib, stroke, mech valve, etc, and people with Cage in Valve for 40 years are walking around and i know one of them, So, yes, good intention, but not proven, so no tks, i will not be a lab rabbit for it. Other than that Very happy with my OnX valve and i dont even know is there, glad i choose it.

 

[vitdoc]

Nope, they told me if I was selected for Eliquis I just take the pills and have to talk to them every month and get periodic blood work.

So the study is not truly “blind”. In any event I can’t imagine why anyone would want to be part of this study since Eliquis failed in a previous study.
Let someone else get or not get a stroke.

 

[Keithl]

Not sure what is different about this study vs previous study. They told me for my age I would have to take 5mg of Eliquis 2x daily. That si a bigger hassle than warfarin and checking INR every 7-14 days.

 

[pellicle]

Not sure what is different about this study vs previous study

I don't know about the previous study, but a blind study is one where the patient (subject) does not know if they are on the placebo or the drug.
a double blind study is where neither the patient nor the people directing the experiment know if the thing the clinicians are administering is the drug or the placebo.

 

[Keithl]

I get blind study, but it was mentioned that a previous @vitdoc mentioned a previous study failed.

 

[Warrick]

 

[BillDaThrill]

I mentioned I was less than impressed with the On-X sampling to get 1.5-2.0 INR approved so was curious how many people in this study. She did not know, but said she would try and find out. .

Re: how many people are currently in the PROACT (On-X eliquis dosage) study, per the Cryolife earnings call from last month, they noted: We continue to make significant progress on the enrollment of our PROACT 10A trial. This is our prospective randomized clinical trial to determine if patients with the On-X aortic valve could be maintained safely and effectively on ELIQUIS versus warfarin. We currently have 471 patients enrolled in this study. Feedback from surgeons and patients participating in the trial remain very positive.

 

[slipkid]

Considering that it sounds like the purpose of the study is to FIND OUT if E is safe OR NOT for On-X patients, I don't know why anyone would even remotely consider enrolling since it being found to be NOT SAFE sounds like a possibility and if so, well, too bad for you.

I saw the horrible effects first hand a debilitating stroke can have on a person (my Mom), basically a fate worse than death being imprisoned in your own body unable to communicate yet being sentient. Agony does not begin to cover it. Death becomes a welcome relief. Keep your E study and shove it up your, er, nose.

To all that enroll I hope it works for them of course though.

 

[Critter]

I don’t understand how there is any advantage since a patient has to take apixaban twice a day versus warfarin qday. Compliance of meds will naturally go down. If you go to 3 times a day ,compliance isn’t going to happen in the long haul with consistency. YMMV.

Only Med that is taken consistently are pain meds. No problem there. That is a topic that stands on its own.

 

[Critter]

Considering that it sounds like the purpose of the study is to FIND OUT if E is safe OR NOT for On-X patients, I don't know why anyone would even remotely consider enrolling since it being found to be NOT SAFE sounds like a possibility and if so, well, too bad for you.

I saw the horrible effects first hand a debilitating stroke can have on a person (my Mom), basically a fate worse than death being imprisoned in your own body unable to communicate yet being sentient. Agony does not begin to cover it. Death becomes a welcome relief. Keep your E study and shove it up your, er, nose.

To all that enroll I hope it works for them of course though.

Sorry about your mom

 

[Unicusp]

Considering that it sounds like the purpose of the study is to FIND OUT if E is safe OR NOT for On-X patients, I don't know why anyone would even remotely consider enrolling since it being found to be NOT SAFE sounds like a possibility and if so, well, too bad for you.

I saw the horrible effects first hand a debilitating stroke can have on a person (my Mom), basically a fate worse than death being imprisoned in your own body unable to communicate yet being sentient. Agony does not begin to cover it. Death becomes a welcome relief. Keep your E study and shove it up your, er, nose.

To all that enroll I hope it works for them of course though.

Agreed. They contacted me as well, a few months back. I declined. I see no benefit and only downside to participating. To me, this is only profit motivated and to try and replace warfarin at 500x the cost. The long list of possible side effects of Eliquis is very scary. No thanks!

 

[Mister_James]

Think of the end results.
You will be anti- coagulated without the additional tests. So you are cutting out the once a week or biweekly INR tests.
Now Warfarin is basically free, other drugs are not so is it really a saving?
Look up the cost for a 30 day Eliquis supply. No wonder someone is trying to push it to more people.

 

[MdaPA]

To me, this is only profit motivated and to try and replace warfarin at 500x the cost.

Look up the cost for a 30 day Eliquis supply. No wonder someone is trying to push it to more people.

The PROACT Xa clinical trial is being funded by CryoLife, Inc. with the expectation that if Eliquis gets approved based on this trial, that it will increase its market share in its On-X aortic valve business. They are hopeful that this then will attract younger patients to choose their On-X AV over other mechanical valves that would have required warfarin or biological valves that would have a higher likelihood of redo/additional procedures.

Note that there are already generic versions (expected to be much cheaper) of Eliquis but wont be available until the patent on Eliquis runs out in 2026 (assuming the manufacture doesn't fight to have it extended again). CryoLife, Inc., is expecting that if all goes well with this trial the FDA may approve Eliquis for On-X AV's by late 2024 or early 2025.

Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve

Generic versions of Eliquis

CryoLife, Q3 2021 Results - Earnings Call

 

[Chuck C]

and people with Cage in Valve for 40 years are walking around and i know one of them,

Yup. We all do. I believe @dick0236 is at about 55 years now and going strong.