On-X reduced anticoagulation therapy clinical trial

[SteveInFlorida]

Hi all!

Sorry I haven't been on the forum since just after my surgery, but both my left hand and my computer were not functioning properly, and so I haven't been active electronically.

However, I now have a new computer and my left hand is doing better, so I wanted to update everyone about my participation in the On-X reduced anticoagulation therapy clinical trial.

Go figure, but I tested unresponsive to Plavix! gosh darnit!

Anyway, I will be thus randomized to either regular warfarin or reduced warfarin. I have been taking a regular warfarin dose now for 2 months without major problem, so I'm more ok with this now than before. Besides, the clinical trial is providing a home testing device, so at least that's a consolation prize.

Anybody else have any updated news about this clinical trial?

 

[Cooker]

As the class clown I will be the first to admit that I am not near as interested in the technical as some are?.it takes all kinds to make the forum go round?..is the trial / term ?reduced? mean less warfarin or no warfarin and more aspirin and Plavix etc?..I am not an OnX patient but I am curious... and if it means ?less? warfarin what would be the use since the way I understand warfarin the amount doesn?t really make a difference??..I?m I being clear as mud again?

 

[SteveInFlorida]

less is more (more or less) for this trial

generally, the trial means either 1) less warfarin or 2) no warfarin, but Plavix & aspirin instead

Less warfarin means only enough to maintain an INR of 1-2 instead of the usual 2.5-3.5, so it is less than half the normal dose a particular individual would be prescribed

however, since Plavix did not have enough effect in my case, my only choice is less warfarin or regular warfarin

Or, I could just say screw it all like many did in South Africa and still be OK

 

[Guest]

Please keep us informed as to what your warfarin dose was for the first two months (just an average is good) and what you average warfarin dose is in the study. I'm mainly interested in if the dose is really 1/2 the previous dose.

 

[SteveInFlorida]

will do, Al.

Pardon my ignorance, I was clearly presuming that it would take proportionately less of a dose to maintain the lower INR, but your post about this reveals my lack of experience in this matter. I am now also very much curious to know how much less of a dose will correspond to the lower target INR.

so far, my target INR has been 2-3, but as close to 2 as possible, a little lower already than normal from my understanding. To maintain that, I started on 2.5 mg/day, but am now up to 3.5 mg/day. So, that will probably be the baseline to compare with after.

 

[Jkm7]

Just for the sake of conversation......

My target range for the 2 1/2 months I was on warfarin was 2.0 - 3.0.

I got up to 80 mg weekly and never got higher than 1.8 before I was permitted to stop the warfarin. (bovine valve).

Some of us metabolize in such a way it takes a large dose of warfarin to reach
a not hugely high level of anticoagulation.

We'd be among those who would skew the numbers of the OnX study.

 

[ALCapshaw2]

less is more (more or less) for this trial

generally, the trial means either 1) less warfarin or 2) no warfarin, but Plavix & aspirin instead

Less warfarin means only enough to maintain an INR of 1-2 instead of the usual 2.5-3.5, so it is less than half the normal dose a particular individual would be prescribed

however, since Plavix did not have enough effect in my case, my only choice is less warfarin or regular warfarin

Or, I could just say screw it all like many did in South Africa and still be OK

Steve,

An INR of 1.0 is the norm for a person with NO anti-coagulation benefit so I checked the ranges with On-X.

The prescribed INR range for AVR patients in the Low AntiCoagulation On-X Study is 1.5 to 2.0

The prescribed INR range for MVR patients in the Low AntiCoagulation On-X Study is 2.0 to 2.5

Full details can be found on their website at
http://www.onxlti.com/pdf/onxlti-clinical-update-24.pdf
which is a copy of their Clinicial Update #24 report.

Note that the usual INR recommendation for AVR patients with mechanical valves and NO additional risk factors is 2.0 to 3.0

and the usual INR recommendation for MVR patients with mechanical valves and NO additional risk factors is 2.5 to 3.5

 

[Guest]

Steve,

It is not your ignorance. I have never seen a person who had their INR range cut in half after they were stabilized on a previous warfarin dose. I just am curious if the dose does get cut in half.

The range you cited for the study is probably because they are interested in whether or not warfarin is necessary. It would be surprising if it was exactly the same range as what they already recommend. Studies are to try niw altenatives.

 

[Guest]

I'm still leary about not having any anti-coagulation. Steve, thanks for participating in the clinical trials. Please keep us posted.

 

[Guest]

I misread Al Capshaw's post. Disregard my last comments about testing new ideas.

 

[ctyguy]

Steve...I concur with Louise in saying thanks for participating. I had my On-X installed almost 5 months ago now. Im curious as well to see not so much what your Coumadin dose is as I am interested in the target INR. My valve replaced my Aortic and I've been told to target 2.0 to 3.0 Im still trying to get my INR to get a bit more consistent. In the last month I've been at 3 to 3.6 and the month prior to that I was as low as 1.7 Im hoping to settle in just above 2.0, maybe 2.2 to 2.3 long term and hope that the study your in bears fruit.

 

[briansmom]

My son is not in the trial, but because of his lifestyle and because his doctors know that the trial is testing a reduced INR, they have set his INR range at 1.7-2.7. We are hoping that the trial goes well. IMHO the no anti-coagulation group must be doing ok, because if they were dying they would have to stop the trial - right?

 

[Guest]

There is a review board that can stop the trial. However, the number of adverse advents has to reach some pre-determined cut-off point that has to do with statistical significance. I think this should have been in the information that you got before signing him up.

 

[SHEEPDOG]

I have the ON-X...

I have the ON-X...

but not in the study. I was just released by my Surgeon to my Cardiologist. The Surgeon and Hospital are not part of the study but he said my target INR would be between 2 and 2.5 but closer to 2 will be fine. I know this range is really small and may never be stable but it is something to shoot for. There is another member whose husband is in the study. When he was on Coumadin, his inr was 1.8 to 2.5. Sounds like my Surgeon has GREAT confidence in the ON-X if he will let my INR be so close to the study INR. I just hope my cardiologist will agree.
Al, is there such a thing as being NATURALLY anti-coagulated? I am a pretty big guy and only need 22.5 or less mg of Coumadin to keep me in range! That was a surprise to the doctors PA as well as the ACT nurse. I know I have had cuts on my shaved head before that bleed for a LONG time despite the direct pressure and all. Could my blood be naturally "THIN" (yes I know that is the wrong term but I used it for sake of the description)

 

[Guest]

You likely need a small dose because your liver enzymes are not very efficient at metabolizing warfarin. That is the most common reason. You might also have a lessened amount of some natural clotting factor (borderline hemophilia) or platelets that are not very active. Without a major work-up, the most telling thing was how badly you bled after the va;ve surgery. Valve surgery is a very high risk procedure for causing bleeding. If you did not require more blood than usual then I would say that all the other stuff is irrelevant.

 

[ejonbry]

My surgeon who will be performing my AVR is on staff at Emory University. He said that after my surgery, he wants my INR at 2.0. He said ON-X is really pushing this study and the positives that have been associated with it so far. He said with continued success, those who have the ON-X valve will no longer require coumadin. He said that was a major deciding point in his pushing the ON-X over the ST. Judes.

Eric

 

[aussie girl]

Can someone explain to me what is meant by "low risk AVR" and "high risk AVR" in the trail report posted by Al

Thanks

Mary

 

[catwoman]

Mary:

My guess is low-risk = no other risk factors, such as no a-fib or history of PE/DVT, etc.

 

[Cooker]

Al...thanks....this is very interesting information....