Proact study completion still years away

[gadoty1]

This is an email that I sent to On-x today. Thought I would share it with you.

Is there any idea how long the proact study is expected to take to be completed? I have an On-x aortic valve but was unable to be in the study. I have had issues with bleeding since being on warfarin but have high hopes that some day I will be able to maintain a lower INR or not take warfarin at all. Thank you so much for all that you do!! Georgia Doty.

Dear Ms. Doty:
Pertaining to your e-mail below, the PROACT study still has over a year to go before we can even hope to publish preliminary results. Patients within the study were asked to commit to five years of follow-up. The AVR High Risk arm (lower levels of warfarin in combination with baby aspirin) completed its target of enrollment early this year, so the official results probably would not be published prior to 5-years hence. However, I suspect there will be preliminary updates in a year or two. That said, it is not likely that a cardiologist would commit to prescribing lower levels of warfarin until all the results are in and analyzed, though some might.

The AVR Low Risk group (Plavix and aspirin only) is still enrolling and at a very slow rate. We are years away from making any sort of comment about clopidogrel and aspirin as an alternative to warfarin and aspirin.

I’m sorry I can’t be more encouraging, but we want to ensure the safety of the patient and the integrity of the study while we’re at it. That’s the way these things go, sometimes. Periodically check our website www.onxvalves.com. I’m sure that when results are available, we will post them there.

I hope your On-X valve continues to serve you well. Best wishes for your continued health.

With regards,
Stephen Ottmers, Ph.D.
Clinical Research Manager
512-339-8000 Ext. 254

 

[Ross]

And this my friends, is why I keep telling people not to make decisions based on what "may be" in the future. The whole thing could fall through in the end and the end isn't even close to being in sight yet.

 

[skeptic49]

Interesting info...thanks for posting this.

Jim

 

[ARGreenMN]

Yep, thanks for the post - helps clarify things a lot on the timing! I should've thought of that, lol, just emailing the manufacturer... Duh... I think I'll do the same to my Regent Manufacturer (St. Jude) and see what their official stance on all this is. I'm sure it'll be even longer out for the Regent (if it ever happens at all), since it's not even officially in the On-X study. But my surgeon (who's involved in a lot of studies like this) indicated pre-surgery that the Regent did have a chance (he said 3-5 yrs out) of not requiring Coumadin someday. As indicated in the reply from On-X, it seems like surgeons/cardiologists must have some latitude to make judgement calls (I suppose at the risk of malpractice suits if they cause a stroke), as mine has recommended a lower than 'normal' INR range for me (1.8-2.2) with my Regent, which I understand goes against the official recommendation of 2-3 for low risk people like me. Just to be a little more comfortable, I'm shooting for 2.0-2.5 instead of 1.8-2.2 (at recommendation of lots of folks including my cardiologist as of yesterday). But again, thanks for sharing the email Gadoty1!!!

I totally agree we should all make decisions based primarily on what is today, not what might be tomorrow. But in my opinion, it is nice to know that someday (even if longer than 3-5 years out), there MAY be a chance of getting off Coumadin. I'm certainly not counting on it, because this and other studies may fall through (as previous studies have done). But for me, it would be nice if it pans out. I'm not saying that living on Coumadin is horrible, or even bad (as most have stated, it actually has a pretty small impact on your life). It's just that I'd like to get away from the periodic finger pokes someday if possible (and hopefully be able to drink more than a couple drinks periodically).

 

[Lynlw]

This is an email that I sent to On-x today. Thought I would share it with you.


Dear Ms. Doty:


The AVR Low Risk group (Plavix and aspirin only) is still enrolling and at a very slow rate. We are years away from making any sort of comment about clopidogrel and aspirin as an alternative to warfarin and aspirin.

I’m sorry I can’t be more encouraging, but we want to ensure the safety of the patient and the integrity of the study while we’re at it. That’s the way these things go, sometimes. Periodically check our website www.onxvalves.com. I’m sure that when results are available, we will post them there.

I hope your On-X valve continues to serve you well. Best wishes for your continued health.

With regards,
Stephen Ottmers, Ph.D.
Clinical Research Manager
512-339-8000 Ext. 254

That's interesting, thanks for sharing. I wonder why "The AVR Low Risk group (Plavix and aspirin only) is still enrolling and at a very slow rate. We are years away from making any sort of comment about clopidogrel and aspirin as an alternative to warfarin and aspirin." is going so much slower. I'm curious if it is because they are having trouble finding elligible people who meet all the requirements to be in that group, or if patients decide not to take the increased risk of stroke, if it doesn't work out as well as they hope, since that is the group they are still trying to reach their target and enrolling people in and the group still taking coumadin is full.

I was just looking at the trial info the other day and noticed at least 1 center that was part of the trial in the beginning, looks (at least by the participating center list) like it isn't part of the trials anymore. I was curious what happened.