There's rosemary, that's for remembrance.
William Shakespeare: Hamlet, Prince of Denmark

Friday, March 06, 2015

I'm a drug trial graduate.....and the story is a long one!

July 2011 I was 13 months post heart attack with 2 stents placed. My nuclear scan was done July 5th. I was positive that 12 months of eating healthy and literally exercising my ass, stomach and boobs off  had reduced my remaining 70% occluded vessel by at least 25%, I would be taken off Plavix the platelet suppression drug that caused the most horrible bruises I had ever seen AND, all of this would be confirmed at my appointment to see my new cardiologist.

I had lost weight the doc said, my blood pressure was great, my heart rate nice and slow, no leg swelling, but, I was still 70% occluded said the nuke scan, Plavix was "cheap insurance" and I would be staying on the drug for quite awhile because another stent was needed and how did August 25th work for me?   Okay, I guess.

On the 25th while waiting in the cath lab patient room we were approached by a woman who identified herself and said she was a research nurse working with my cardiologist, Eli Lily and Daiichi Sankyo.  There was a drug trial going on that included the type of stent I was going to have inserted (drug eluting Paclitaxel), an oral drug similar to Plavix called Effient and daily aspirin.  She gave us a packet of information to read, my doc came in the room and fully explained the trial and said I was an excellent candidate.  I would get the drug free for at least a year (big benefit there because Plavix cost a bunch at that time), be monitored every 3 months by my doc and the research nurse, and get 50 bucks for each of the visits.  The point of the see if short(er) or long term platelet suppression therapy helped prevent cardiac vessel occlusion in conjunction with the stent drug and aspirin therapy.   I signed on the dotted line.

Here's how the trial was going to work.  It was a 5 year trial. Every patient enrolled would absolutely get the drug for the first year.  People included in the trial had stents placed, had an acute heart attack or other qualifying cardiac event.  After a year the patient (or number actually) would be double blinded and only the dispensing body would know if the patient was then getting drug or placebo.  Aspirin was to be taken every day.

It seemed to me that anyone with half a brain would know if they were on drug or not because of the nasty side effect of bruising. I continued to bruise if I looked at my arms or legs the wrong way, Steve looked at me the wrong way, I turned over in bed or simply took a deep breath.  From month 13 through month 30 I was to bipp along taking my drugs, seeing the research nurse, seeing the doc every 6 months and depositing my nice little check.  At month 30 I would be taken off drug or placebo, continue aspirin, see the research nurse every 6 months and deposit my check.  Sounded okay to me.

Month 30 was approaching and the nurse called to make my appointment.  She told me she had some important things to discuss with me and that a new consent would be needed to continue in the trial.  Warning bells went off.  Sure enough, there were important things said.

I was un-blinded.  Yes, I was on the drug and surprise I was going to stay on the drug for at least another year. Why? Because as the trial had progressed it was found that people who had been on the drug and then taken off at month 30.... well, a large number of them had cardiac events within 15-21 days of going off drug.  None of the events were fatal.....well, thank goodness for that.....but, more information was needed and rather than put those of us left in the trial at risk, we were to continue taking Effient.  At that point in time our results were going to be merged with another world wide trial called The DAP Trial (dual anti-platelet) that included Plavix and other variations of stents, drugs, etc. I would be seen at the end of month 42 and would find out what was decided then.  I deposited my check.

Month 42 appointment was yesterday.  I am/was one of the last people in the trial, # 1525/118, and the trial will be fully closed in 2 weeks.   The paper had been published (yes, we had read it) and the results one is sure whether keeping patients on long term platelet suppression drugs helps or not, but for sure it must be providing some sort of protection as evidenced by those poor folks that had events after month 30.

We had a really nice conversation, my cardiologist wants me to stay on either Plavix or Effient (I suspect it will be Effient) long term which in doctor language means til the casket drops, I was given 2 weeks of sample Effient and a script will be called in to my pharmacy.  My check is in the mail and will be deposited before the endorsement ink is dry.

If I typed trail instead of trial....sorry.....either way it has been a long trail in the trial.