ON-X study

[bradvo]

I signed on for the study when choosing the On-x valve.

Couple weeks back after going thru the plavix 10 day trial along with my normal coumadin intake I was told I was accepted in the trial but not sure which
arm I would be in, either coumadin or Plavix.

Yesterday I got the call and was told I will be staying on coumadin.
In mid Feb, I will be going to there office and they will be checking me out, EKG and whatever else??
I then will be given my home INR meter and free drugs for the study. Before getting the meter I will have a training session on it's use, then told what
my INR target numbers should be.

Cool to have my own meter and drugs paid for.

Brad

 

[Jkm7]

Great they will give you a home meter.
Best wishes.

 

[Bina]

I like the idea of staying on Coumadin and getting the free stuff. Excellent !!

 

[Phil]

Great news Brad. Having pretty much decided on a mechanical valve replacement I hope I can get onto one thing similar here (Australia).

Sounds like all is going swimmingly with your recovery. Well done!

All the best.


Phil.

 

[bradvo]

I got no complaints and the medical check ups are a big plus to me.

Bina, I think your right. Lyn got me thinking and coumadin is proven for us valvers.

 

[bradvo]

Great news Brad. Having pretty much decided on a mechanical valve replacement I hope I can get onto one thing similar here (Australia).

Sounds like all is going swimmingly with your recovery. Well done!

All the best.


Phil.

Good luck with that Phil, I wish ya success.
Brad

 

[Lynlw]

I got no complaints and the medical check ups are a big plus to me.

Bina, I think your right. Lyn got me thinking and coumadin is proven for us valvers.

Do you know what your range will be? The standard dose or lower (1.5-2 i believe) or is this something you find out when you go for the machine and training?

 

[bradvo]

Do you know what your range will be? The standard dose or lower (1.5-2 i believe) or is this something you find out when you go for the machine and training?

That sounds about right, thought I heard a low of 1.5 or 1.6.
Currently my range is between 2.0 and 3.0 , I have stayed at 2.0 my last 2 checks at 32.5 mg's a week. So it will be interesting to see what adjustments will be made.
I will have 1 more INR check at the coumadin clinic before I enter the study, so if I am still at 2.0 then It should be easy for everyone.

 

[normofthenorth]

This reminds me of some randomized trials where the results are compromised by the fact that the chosen placebo actually has clinical benefits. In this case, thWarfarin/Coumadine Plavix is apparently being compared to Warfarin/Coumadin with home monitoring and free Warfarin/Coumadin. But most ACT patients DON'T have home monitoring and free Warfarin/Coumadin, so there are two variables that have to be teased out to get the full answer.

 

[bradvo]

Not sure I follow your questioning about results being compromised. My 10 day trial I mentioned above had to include Plavix so blood could be drawn at the end to see if I even qualified for the study group, hope that clears it up some.
The study does not have you on 2 separate thinners, it is either Plavix or Warafrin/coumadin.
Any member in this study that is on the warfarin /coumadin will be supplied a home meter and warfarin/coumadin free of charge.
The Plavix study group will not require the home meter but the plavix meds will be supplied free of charge.
Random sampling of blood between the 2 groups will then be tested by the study group for around 6 to 8 years.
Other medical benefits of the study include echo scans, not sure if annual or not but think it is. They also pay you for each visit, more of a fuel cost to get you in for the testing.

Brad

 

[normofthenorth]

I just meant that the "control" group will almost surely do better than the avg. population of ACT users, who DON'T get free home testers and free Warfarin.

 

[Lynlw]

That sounds about right, thought I heard a low of 1.5 or 1.6.
Currently my range is between 2.0 and 3.0 , I have stayed at 2.0 my last 2 checks at 32.5 mg's a week. So it will be interesting to see what adjustments will be made.
I will have 1 more INR check at the coumadin clinic before I enter the study, so if I am still at 2.0 then It should be easy for everyone.

I'm curious are you also taking some strength of aspirin? I found it interesting for the study it looked like in addition to whatever anticoagulant you are on and what strength , they also are on aspirin, which makes it different than "standard care" and would probably lessen the odds of having a clot anyway. It would make more sense to me if they wanted to prove there would be less clots with my valve at a lower range or even normal range, I would just have patients take the Coumadin like is standard care.

Did you happen to find out HOW the people who are on the lower INRs of Coumadin are doing in the data so far? The prelim results I was able to find showed a increase in clotting in the lower INRs and an increase in Bleeds in the standard INR (which kind of makes sense) So IF it were me possibly being put in the arm that has a lower INR, I would probably want to know any data they have already, if there was any possibility it would increase the likely hood i ended up with a stroke. But I personally fear strokes more than death.

 

[sarahsunshine]

I agree that if we are going for a study to simply show that low dose coumadin works, then it should be ONLY low dose coumadin.

On the other hand, if we can decreased the clotting and keep low dose coumadin by adding an aspirin, then overall, that would show that low dose coumadin + aspirin is as safe as the higher doses of coumadin. Personally, I would rather be (or have Skyler be) on low dose coumadin with aspirin than high dose coumadin.

So, if the study is to see if we can lower coumadin safely, with aspirin, then that's a fine purpose as well.

Please keep us posted. Many of us have stakes in the results!

 

[bradvo]

I'm curious are you also taking some strength of aspirin? I found it interesting for the study it looked like in addition to whatever anticoagulant you are on and what strength , they also are on aspirin, which makes it different than "standard care" and would probably lessen the odds of having a clot anyway. It would make more sense to me if they wanted to prove there would be less clots with my valve at a lower range or even normal range, I would just have patients take the Coumadin like is standard care.

Did you happen to find out HOW the people who are on the lower INRs of Coumadin are doing in the data so far? The prelim results I was able to find showed a increase in clotting in the lower INRs and an increase in Bleeds in the standard INR (which kind of makes sense) So IF it were me possibly being put in the arm that has a lower INR, I would probably want to know any data they have already, if there was any possibility it would increase the likely hood i ended up with a stroke. But I personally fear strokes more than death.

I don't know what others are prescribed, all I can say is what I was told to take at hospital and aspirn was part of the med group. This was before the study even begins, study does not start for 3 months post op.
Yes 81mg of aspirin is also part of study with a INR range, so does anyone else get aspirin the first 3 months ??? I dunno ??

Like Sarah is leaning, I believe it is better with less dose of warfarin, maybe not tho. In the whole scheme of things I think this is a very slow process. Plavix is thinners, warfarin is thinners, aspirn is thinners. If they want to know if they can avoid thinners , don't give any ...right!
But who the heck in their right mind would sign up for that . .......

 

[dtread]

I'm curious are you also taking some strength of aspirin? I found it interesting for the study it looked like in addition to whatever anticoagulant you are on and what strength , they also are on aspirin, which makes it different than "standard care" and would probably lessen the odds of having a clot anyway. It would make more sense to me if they wanted to prove there would be less clots with my valve at a lower range or even normal range, I would just have patients take the Coumadin like is standard care.

Daily Aspirin in addition to Coumadin/Warfarin is the Standard of Care for Valve Patients as per The ACC/AHA 2006 Guidelines for the Management of Patients with Valvular Heart Disease; http://content.onlinejacc.org/cgi/content/full/48/3/e1?ct

Refer to Section 9.2, # 8: "The addition of aspirin 75 to 100 mg once daily to therapeutic warfarin is recommended for all patients with mechanical heart valves and those patients with biological valves who have risk factors.* (Level of Evidence: B)"

Also Section 9.2.1, 2nd Paragraph: "The addition of low-dose aspirin (75 to 100 mg per day) to warfarin therapy (INR 2.0 to 3.5) not only further decreases the risk of thromboembolism (808,946,950–953) but also decreases mortality due to other cardiovascular diseases. A slight increase in the risk of bleeding with this combination should be kept in mind (950,954). The risk of gastrointestinal irritation and hemorrhage with aspirin is dose dependent over the range of 100 to 1000 mg per day, and the antiplatelet effects are independent of dose over this range (955,956). There are no data in patients with prosthetic heart valves receiving warfarin and aspirin in doses of 100 to 325 mg per day. Doses of 500 to 1000 mg per day clearly increase the risk of bleeding (957–959). The addition of aspirin (75 to 100 mg per day) to warfarin should be strongly considered unless there is a contraindication to the use of aspirin (i.e., bleeding or aspirin intolerance). This combination is particularly appropriate in patients who have had an embolus while undergoing warfarin therapy, those with known vascular disease, and those who are known to be particularly hypercoagulable. As an example, such combination therapy is recommended by a committee concerning the use of antithrombotic therapy in women during pregnancy (807). The method of anticoagulation in pregnant patients is controversial and is discussed in Section 5.8."

 

[bradvo]

Yesterday was my first appointment for the study, they checked heart rhythms and then off to pharmaceutical to learn about my INR target levels and how to use my home
meter.
I was surprised to learn my INR levels do not change, I am to continue to stay between 2.0 and 3.0. I checked at 2.0 and have been there for a month, so she raised my dosage to reach 2.5.
OK by me, I'm feeling pretty good today.

Brad

 

[bdryer]

Hi Brad

I was implanted with an On-X 23 mm Av on Mar 21/11

I have been home testing for several months. Have not been to the lab for several months and have been released by the anti couagulation clinic. They want me to send my INR readings to my PCP. No such thing will happen. I have been practicing with the Online calculator as posted on this site and the calculations have been spot on with the clinics recommendation.

I am keeping myself close to an INR of 2.1. I do take a daily 81 mg dose of ASA. My Warfarin dose is 8 mg. I eat 2-3-4 servings of greens daily. So far so good.

Good luck. Looking forward to seeing an INR of 1.5 to 2.0 for us On-X recepients.

 

[normofthenorth]

Bdryer, what's so bad about sharing your INR readings with your PCP, while continuing to manage your own dosage using the calculator? When I was on ACT, my PCP phoned me with my INR results (from the lab) and then we discussed and "negotiated" how I would change my dosage, when I was out of range. I'd think a good PCP should be happy to let you take the lead, while appreciating the info.

 

[bdryer]

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.

 

[normofthenorth]

Bd, I agree completely! Getting your ACT/INR right is important, but getting a good PCP, and a good relationship with your PCP, is probably way MORE important. Once you've got that, sharing the INR readings should be a Good Thing. (And if push really comes to shove, the PCP isn't in your house counting the pills you take!)