San Fran asked when this futility analysis may take place. Tough question to answer. We would need to know the status of enrollment in BETonMACE to answer this.

What we do know is that the patient population in BETonMACE is quite similar to those studied in the EXAMINE trial. Similar to the EXAMINE trial, BETonMACE will require patients to have diabetes AND have had an acute coronary syndrome event within 7-90 days of randomization in the trial AND will be using the narrow 3-point MACE (death, myocardial infarction, stroke).

EXAMINE had a 3-point MACE event rate of about 10.5% at 18 months (about the same for treatment and placebo groups). The event rate in BETonMACE might even be projected to be even higher in the placebo group, since there is an additional criteria of having low HDL. However, I don't know the HDL levels of those in EXAMINE, so this may be a non-issue.

We are only 3 months past first patient dosing. Without any concrete info on number of patients enrolled/starting dosing and number of total study sites activated, it is impossible to project. However, I recall enrollment projected to take 1 year and total trial dosing period to be 2 years. So first patients in (starting in November 2015) would be dosed 2 years and last patients in (probably around November 2016) would be dosed for 1 year by the time the dosing period ends around November 2017.

BearDownAZ