Proact Xa / apixaban trial for On-x valves

[Al3x]

It looks like the Proact Xa trial has been closed due to poor results. Looks like it's Warfarin for life!

https://www.prnewswire.com/news-rel...-stop-proact-xa-clinical-trial-301631774.html

 

[Emmapenny]

It looks like the Proact Xa trial has been closed due to poor results. Looks like it's Warfarin for life!

https://www.prnewswire.com/news-rel...-stop-proact-xa-clinical-trial-301631774.html

That’s a shame - feel a bit disappointed as it looked so promising.

 

[dick0236]

It looks like the Proact Xa trial has been closed due to poor results. Looks like it's Warfarin for life!

Never say never. Anti-coagulation meds are too big a market for the Pharma companies to walk away from. BTW, I've taken warfarin virtually all of my adult life (age 31 to 86+) and have always found the drug to be efficient and predictable...........
........if I do three simple things:
1. Take the pill as prescsrbed
2. Test INR routinely
3, Don't RUN with scissors in your hand!

 

[pellicle]

That’s a shame - feel a bit disappointed as it looked so promising.

well so far I think that the addition of Point of Care monitoring has taken away any of the significant benefits of all these agents while not adding in the significant additional drug costs.

Last two times they've found that "one size slips all" (no not a typo) actually doesn't work as well as the drug we already have does right now.

I keep coming back to the observation that all previous problems with warfarin and everything that gives it a bad RAP sheet is down to the simple issue of managing dose.

Wasn't available when President Truman took it but sure is now.

Unlike diabetics who need to test their blood sugar not just dialy but hourly for best effect, for us its weekly.

A finger prick weekly and a small amount of thought once a week and voilla.

 

[treichert0312]

It looks like the Proact Xa trial has been closed due to poor results. Looks like it's Warfarin for life!

https://www.prnewswire.com/news-rel...-stop-proact-xa-clinical-trial-301631774.html

I was on the verge of enrolling in the trial - just got the news with no explanation. Figures the study had reached capacity. Glad to get the info here.

 

[BillDaThrill]

It looks like the Proact Xa trial has been closed due to poor results. Looks like it's Warfarin for life!

https://www.prnewswire.com/news-rel...-stop-proact-xa-clinical-trial-301631774.html

Thanks for posting this. Was trying to keep up with the Proact Xa study.

 

[vitdoc]

I was on the verge of enrolling in the trial - just got the news with no explanation. Figures the study had reached capacity. Glad to get the info here.

I always wonder why anyone would sign up for this trial. The upside would be no testing and maybe less bleeding. The downside could be a stroke.
That would make me very uncomfortable. I am amazed how a trial like this gets people to sign up.

The other issue that comes out is sometimes things seem to be OK in a trial but when the item is FDA approved and goes out into the wild things show up that were not seen (or at least reported) in the trial.

Just recently a new drug for macular degeneration was FDA approved. Within a few months a bunch of cases of severe eye inflammation showed up some of which were permanently blinding . As soon as I became aware of these issues I stopped using the drug even though the incidence was relatively low.
I always apply the test "what would I want to have done to me" to things I do to patients. I don't want to go blind even if the chances are low especially when other drugs exist that are perfectly adequate. Also I don't think I would do well with a stroke.

I think the key thing that has made the use of warfarin much more palatable and safer is home testing. I don't think any of the studies that compared novel anticoagulation agents to warfarin had the warfarin population do home testing. So the variation in the INR in the non self testing population probably is significantly more variable than in the self testing population. If the studies purporting to show the advantages of the novel agents were done with a self testing population than I would not be surprised if the bleeding issues would be much closer than the drug companies studies showed. Again another way the studies are set up by the drug companies to make their agents have the best chance of success.

 

[Superman]

Why do I feel like On-X will continue to put people at risk in an effort to differentiate themselves from other mechanical valves already on the market? Curious what their next trial will be.

It really is a good valve. They could just let it stand on it’s own merits.

Any real break through will be if someone ever designs an artificial valve that requires no ACT and lasts a lifetime.

 

[Emmapenny]

well so far I think that the addition of Point of Care monitoring has taken away any of the significant benefits of all these agents while not adding in the significant additional drug costs.

Last two times they've found that "one size slips all" (no not a typo) actually doesn't work as well as the drug we already have does right now.

I keep coming back to the observation that all previous problems with warfarin and everything that gives it a bad RAP sheet is down to the simple issue of managing dose.

Wasn't available when President Truman took it but sure is now.

Unlike diabetics who need to test their blood sugar not just dialy but hourly for best effect, for us its weekly.

A finger prick weekly and a small amount of thought once a week and voilla.

I’m feeling more relaxed about warfarin than I was a few weeks ago. I can see the testing won’t really be an issue further down the line (currently we are still testing 2/3 times a week - clinic request) so it will be nice when that reduces. And if it was me taking it age 48 then I’d likely not even have been following the potential of a new option. However, when your 15 your lifestyle tends to be far from consistent, from being super active one week to lying around the house not doing much the next. Eating for 2 some days not eating much for others. Depending on social plans and school etc. So the idea of a pill that took away that uncertainty of dosage was appealing.
Consistency I think is much more normal as you get older!

Also the varying messages about INR on an onx valve being no longer relevant was appealing.

I came across your post when you mentioned about people who never took any anticoagulant and this reminded me of the nurse who gave me my initial session on warfarin / scared the life out of me. She told me that she doubted warfarin would ever change as there is a socio economic issue removing it due to the amount of people working in clinics involved in managing everyone. I’ve no idea if this is in anyway true or realistic but the thought of my son (or anyone ) being on such a medication based around not upsetting the economy makes me feel bad. Maybe that’s another thing she told me i just need to get out my head ??

I guess it part of the coming to terms with my sons new world . I’d prefer it for him if there was a tablet he could take without thinking. But obviously if it’s not the best option then it’s not an option.

 

[pellicle]

... Also the varying messages about INR on an onx valve being no longer relevant was appealing...

hey, there's a lot to unpack in the above post and I don't quite know where to start or indeed if my take on all of it is even correct.

However let me say that as we shine a light around the room we gradually build up a picture of what's really there in the darkness and (hopefully) come to the conclusion that there really aren't any monsters here.

I've tried to in what little way I can be that light in the darkness of OHS and the various options, in part because I know its a journey of understanding.

I believe I was lucky (or perhaps just started early, 10 yo as you may know) to rationalise all the things that happened into a good understanding based on a sound grounding in reality. Many get instilled with fears and half truths.

I do what I can to try to herd people into a good and rational view of this whole thing, especially younger people (who are often the most effected by these things).

Best Wishes

 

[pellicle]

I guess it part of the coming to terms with my sons new world

dunno if this helps but I once wrote this about my mum
https://www.valvereplacement.org/threads/so-upset-my-baby-has-bav.42802/post-786328(and no I didn't write as a mother ... which is in the previw)

 

[Timmay]

Why do I feel like On-X will continue to put people at risk in an effort to differentiate themselves from other mechanical valves already on the market? Curious what their next trial will be.

It really is a good valve. They could just let it stand on it’s own merits.

Any real break through will be if someone ever designs an artificial valve that requires no ACT and lasts a lifetime.

Although I am sad that some individuals were harmed , I DO think it is a good idea to keep trying to move forward. The new anti-coagulation drugs really did need to be tested to see if they would work (IMHO). This is not me saying that anything is inherently wrong with Warfarin - not at all - not even close. Totally happy to be on such a proven drug.

 

[pellicle]

I always wonder why anyone would sign up for this trial. The upside would be no testing and maybe less bleeding. The downside could be a stroke.
That would make me very uncomfortable. I am amazed how a trial like this gets people to sign up.

I'm going to call it the psychology of ignorance; we see this (often through no fault of the person) every time we hear "if I'd known this before I got hurt". Perhaps also its mixed with the psychology of magical thinking and hope, and also (after all) people buy lottery tickets all the time despite (in theory) having gone to school and learned about the odds.

However what I find the most reprehensible is the people who aren't even profiting from "hope" who come here and poohoo every point made by rational and experienced (often multiple decades) members here who offer advice on "the what's what" of anticoagulation. Invariably its the people with (either) no or the very least experience on ACT who sledge it.

"Don't just listen to some anonymous person on the internet, listen to your doctor" ... apparently these people never seek "second opinions".

 

[pellicle]

I DO think it is a good idea to keep trying to move forward. The new anti-coagulation drugs really did need to be tested to see if they would work (IMHO).

here's the thing, they ARE tested before they go to trial. Often that testing reveals flaws but they "cook the data" to get it through to enable a public trial.
CryoLife in particular has more of this in their history than any other valve maker that I can think of.
To my mind (and I have friends who I went to Uni with who quit because of ethics) it takes a particular type of person to keep working in research in the face of "lets discount this data and apply for a trial".

To be clear its not every researcher, but we have reached that part of the curve when the amount of research to uncover a new drug makes the cost benefit pretty much an asymptote.

The low hanging fruit has been picked already.

Meanwhile warfarin has been in public circulation for some time:

​

Warfarin was formally approved for human use by the U.S. Food and Drug Administration (FDA) to treat blood clots in 1954. In 1955, warfarin's reputation as a safe and acceptable treatment was bolstered when President Dwight D. Eisenhower received warfarin following a massive and highly publicized heart attack.​

(wikipedia)

Since then we've (in the face of fierce opposition from vested interests) introduced much better outcomes with self testing and self administration (some pockets of financial resistance remain)

 

[Juli]

I am really feeling good about this self inflicted disaster that this company brought upon themselves. So much confusion and misguidance regarding anticoagulation recommendations with dangerously low INR ranges.

The only real low value is currently the share price (-35% since last week) and I will definitely listen to their next earnings call on November 2 - can’t wait for what management has to share.

Maybe they change their name again?