RE:RE:J & J XARELTOToniv,
Thanks for sharing about the early stop of the COMPASS trial. BTW, Ron the link worked fine for me. Here is the link to the clinicaltrials.gov page for the COMPASS trial for reference: https://clinicaltrials.gov/ct2/show/NCT01776424
This trial included 27400 patients studies for up to five years (start date Feb 2013, anticipated end date March 2018). So they stopped it an entire year early. Very interesting.
Personally, I don't think they will or should stop BETonMACE early. If the trial plays out as planned, then they will have not just efficacy but long term safety data on patients with an average of 18 month drug treatment (first patients in on drug for 24 months, last patients in on drug for 12 months). With only 2500 patients for a Phase 3 cardiovascular outcome trial, I think BETonMACE needs to be completed as planned.
However, IF the data safety monitoring board make an early call on BETonMACE (a big IF), and IF the European EMA and possibly US FDA are willing to allow approval of BETonMACE for reduction of MACE events in high-risk CVD patients WITH a results of A FUTURE long-term safety trial pending, then I'm OK with that. :-)
BearDownAZ