ON-X study

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Hi Norm

My main reason is confidence in the ability of the PCP to be as accurate and experienced as the anti-coug clinic, or the "on line calculator". I interviewed a PCP regarding how he makes the INR adjustment, he said he makes a call from experience with no reference to any calculator or formula. That shattered my confidence on any prospective call. I have chosen a different Dr. to act as my PCP. I have judged their ability even before sampling their results. Makes me a bad judge as I have proven them guilty before the trial. [A poor example of western justice from days gone by].

You do have a point, perhaps I should give them a shot. After all I am backed by my own and proven research.

Eventually I will have to go the the lab for a draw. This will allow me to compare my home tester with their pro-time readings, hence accomplishing a calibration of my device. The lab is required to send the readings to my PCP. Thus I will experience his proficiency.

My only question would be who is writing the scripts for your Coumadin and will they agree to write the scripts and basically take the responibility/blame if anything "bad' happens, if you don't report your tests etc?
 
I got my On-X on Jan 13, 2012.
I am not officially part of the PLAVIX study, however my surgeon put me on 325mg Aspirin a 1.5-2.0 range of coumadin. I am now on a 2-3 range of coumadin because I got a-fib shortly after surgery.

As an FYI, tho, I found the 1.5-2.0 range to be really hard to maintain. 2-3 is easy to maintain and I stay in range much better.
 
Hi Lyn

I'm banking on the cardiologist rewriting the prescription. He does not adjust patients INR but he holds the pen. With proven competence in the knowledge and ability of his patients he will make a stand for you. He was huge in helping me bring the On-X brand to my home city, which allowed me to be this towns first recipient. I will show him my self managed test results and dosing calender as proof of competence.

I must say, your legality question may cause a road block. I'll see the cardiologist this Mon for my annual. I will see if I will go along with what I have assumed.
 
Our clinic writes out the prescription in 1 year increments, assuming that dose will change periodically. Honestly, I don't think they keep track and just expect us to call in when we need more. Then we simply tell them the current dose and the size of pills we need. We do have to write up our INR test results every two months and submit them. If something got consistently out of range, they may decide to remove us from the homs monitoring group. I think it would take quite a while for that to happen, though. Years?
 
Hey Norm

Indeed you are right about having a great PCP. I recall when I interviewed my present PCP, [who recently immigrated from Egypt to Canada], he told me he is very experienced with home testing from his native country. He told me to phone my results to him and he will adjust as required. I am really hoping that a personal and up close appt. is not required and he is good about an over the phone consultation. The wait times for any thing medical in my province are brutal. One of the prime reasons for home testing was to eliminate using up a significant amount of time for basic routine medical procedures, like testing your INR.

Analyzing myself, 11 months post-op, I think I got a little carried away with how I am going to take charge with my home testing device and on-line calculator software. It's great having folks here, kinda like me, supporting and offering advice and guidance from experience and bringing to my mind scenarios and questions that I never considered.

Hi Sarasunshine, same deal here with the medical pros, they write a multi dose prescription for 1 year. I have them include dosages from 1-6mg.

My apologies to bradvo for diverting attention from his thread to me. So what about the On-X study...... Personally I have been giving it some thought, but only for maintaining an INR between 1.5-2.0 plus an 81 mg dose of ASA. No Plavix for me! As for now I'm keeping my INR close to 2.0 along with an daily 81mg dose of ASA, which is as close to the study that I may get.
 
Keeping INR within a 0.5 spread (like 1.5-2.0) is naturally much trickier than keeping it within a 1.0 spread (like 2.0-3.0). Naturally. The online calculator I've seen only deals in the bigger targets.
 
Do you guys have a link for the On-X study? I chose On-X for my future AVR surgery and am wondering if this study is still open?
 
Do you guys have a link for the On-X study? I chose On-X for my future AVR surgery and am wondering if this study is still open?

http://clinicaltrials.gov/ct2/show/study/NCT00291525?term=on-x+valve&rank=1&show_locs=Y#locn is the link to the clinical trial info. Where are you havig your surgery? the centers taking part are at the bottom of the link. FWIW I personaly would think very hard IF I were a young person and one of the risks is increased chances of having a stroke at the lower INRs. But I personally always feared a bad stroke over death.
 
Do you guys have a link for the On-X study? I chose On-X for my future AVR surgery and am wondering if this study is still open?

Edit: Ok, just ignore this, Lyn just provided the same answer as I was typing.. :)

I believe only certain arms (risk and treatment groups) are still recruiting, not all, and it's being done in a specific group of 30-40 centers in the US. Here's a link to a clinical trial site that includes those centers: http://clinicaltrials.gov/ct2/show/study/NCT00291525?show_locs=Y#locn

The principal investigator was a colleague of my surgeon, so I know a little bit about it even though I didn't end up getting the On-X. I'm sure Brad will have much more to add though since he's been through the process.
 
bdryer no problem with your participation, that is what these threads are for.

I'm still pretty green to the study since I just had my appt. last week.
I can tell ya that in this study I am now under my surgeons care, not so much the cardiologist. I have to report my INR to two facility's each week, one to my surgeons pharmaceutical medicine office and the other to Alere who owns the meter and also monitors my INR targets.
I will not be dropping my target below my already selected range of 2.0 to 3.0 as far as I know.
I just received my last coumadin clinc bill of 118 bucks, nice that I will no longer be paying for this service. My insurance is good , but the first 3,500 is on me. That is nothing when having open heart, but after that it tends to nickle and dime ya.
My primary reason for signing up was ;
I would have medical test done at no cost to me.
I would have home monitoring meter and free supply of test strips paid by ON-X ( thought meds were included but was wrong)
I would have test each week to better control INR ( if needed, mine is pretty easy so far).
I liked the fact that my surgeon is in charge.

Personally , I couldn't be happier .
 
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