I'm guessing we're close to being due for another DSMB update, based on the timing of the first three....or conversely I'm wondering if they'll just hold off if the FA is close.  

Obviously here's hoping for some robust numbers....and while it bites that people have to suffer through a MAC event, up to and including death, to advance this science....ugh.  The criteria for participants puts them at an incredibly high risk for a MAC event in any case.  

Inclusion Criteria:

• CAD event 7-90 days prior Visit 1 w/ 1+ of following 3 primary criteria:
• Unstable angina w/ each of the following: 1. characteristic ischemic pain or discomfort in chest/associated referral areas, occurring at rest/with minimal exertion 2. ECG changes consistent with acute myocardial ischemia based on new/presumed ST elevation/depression or T-wave inversion 3. objective evidence of obstructive CAD based on 1+ of the following: a. new/presumed new evidence of myocardial ischemia/infarction by perfusion imaging b. new/presumed new regional wall motion abnormality c. current evidence of at least 1 epicardial coronary artery stenosis ≥70% by coronary angiography d. need for coronary revascularization related to index ACS event
• History of PCI w/ or w/o coronary stenting to treat acute coronary syndrome 7-90 days prior Visit 1
• Prior MI 7-90 days prior screening w/ 2 of following 3 criteria: 1. characteristic ischemic chest pain/pain in associated referral areas 2. Elevation of troponin T/I or CKMB if troponinT/I is unavailable at local lab (at least >ULN for lab) 3. Development of new Q-waves in ≥2 adjacent ECG leads or development of new dominant R wave in V1
• Documented diagnosis of T2DM (1+ of the following criteria)
• Documented history of T2DM
• History of taking diabetes medication
• HbA1c ≥6.5% at Visit 1
• For males HDL-C<40 mg/dL(1.04 mmol/L), for females HDL-C<45 mg/dL(1.17 mmol/L) at Visit 1
• Subjects currently not on high intensity statin therapy could start rosuvastatin at Visit 1 and those currently on therapy besides atorvastatin/rosuvastatin can be switched to rosuvastatin at Visit 1
• Female subjects of non-childbearing potential (post-surgical sterilization/post-menopausal) or if childbearing potential have neg urine pregnancy test and be willing and able to use non-hormonal birth control (non-hormonal IUD, condom or diaphragm) or remain abstinent from Screening to Follow-up Visit