Clinical trial NCT02586155 (phase 3, status: active, not recruiting)
Conditions: diabetes mellitus, type 2, coronary artery disease, cardiovascular diseases
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44, I25.10, I25.110, I25.119, I25.111, I25.118, A52.00, A52.09, A50.54, Z01.810, Q87.418, Z13.6, R94.30
Drugs: rvx000222, placebo (for rvx000222), atorvastatin, rosuvastatin
SMILES: COC1=CC2=C(C(=O)N=C(N2)C2=CC(C)=C(OCCO)C(C)=C2)C(OC)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(=O)O)N(C)S(C)(=O)=O
Eligibility criteria:

        Inclusion Criteria:

        • CAD event of either unstable angina or myocardial infarction 7-90 days prior Visit 1:

        Unstable angina: for a qualifying unstable angina event, each of components (a), (b), and
        (c) must be satisfied: a.) Characteristic ischemic pain or discomfort in chest/associated
        referral areas, occurring at rest/with minimal exertion b.) ECG changes consistent with
        acute myocardial ischemia based on new/presumed ST elevation/depression or T-wave inversion
        c.) Objective evidence of obstructive CAD based on 1+ of the following: i. New/presumed new
        evidence of myocardial ischemia/infarction by perfusion imaging ii. New/presumed new
        regional wall motion abnormality iii. Current evidence of at least 1 epicardial coronary
        artery stenosis ≥70% by coronary angiography iv. Need for coronary revascularization for
        the index ACS event, including a percutaneous coronary intervention (PCI) with or without
        coronary stenting.

        Prior MI 7-90 days prior screening treated with or without a percutaneous coronary
        intervention (PCI). For a qualifying event of MI 2 of the following 3 criteria must be
        satisfied: a.) Characteristic ischemic chest pain/pain in associated referral areas b.)
        Dynamic elevation of troponin T/I or CKMB if troponinT/I is unavailable at local lab (at
        least >ULN for lab) c.) 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, and/or 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

          -  Give signed informed consent

        Exclusion Criteria:

          -  Heart disease which will w/in 90 days of Visit 1 likely need coronary bypass, PCI,
             cardiac transplantation, surgical repair and/or replacement

          -  Previous/current diagnosis of severe heart failure or documented LVEF<25% determined
             by contrast left ventriculography, radionuclide ventriculography or echocardiography.
             Absence of LVEF measurement in subject w/out a previous/current diagnosis of heart
             failure does not exclude entry into study

          -  Evidence of cardiac EP instability incl. history of uncontrolled ventricular
             arrhythmias, atrial fibrillation/flutter or supraventricular tachycardias w/ a
             ventricular response HR>100bpm at rest w/in 4 wks prior Visit 1

          -  CABG w/in 90 days prior Visit 1

          -  Evidence of severe renal impairment as determined by either eGFR<30 mL/min/1.7m2 at
             Visit 1 or current need for dialysis

          -  Uncontrolled hypertension defined as 2 consecutive measurements of sitting BP of
             systolic>180 mmHg or diastolic>100 mmHg at Visit 1

          -  Treatment w/ immunosuppressants w/in 12 mos prior Visit 1

          -  Use of fibrates at any dose or niacin/nicotinic acid 250+ mg w/in 30 days prior Visit
             1

          -  Known allergy/sensitivity to any ingredient in IMP

          -  History of intolerance to atorvastatin/rosuvastatin

          -  Triglycerides>400 mg/dL (4.52 mmol/L) at Visit 1

          -  Any medical/surgical condition which might significantly alter absorption,
             distribution, metabolism or excretion of medication

          -  Evidence of cirrhosis from liver imaging/biopsy, history of hepatic encephalopathy,
             esophageal/gastric varices, active hepatitis or prior porta-caval shunt procedure or a
             Child-Pugh score of ≥5 points

          -  ALT/AST>1.5xULN by central lab at Visit 1

          -  Tot. bilirubin>ULN by central lab at Visit 1

          -  History of malignancy of any organ syst treated/untreated w/in the past 2 yrs whether
             or not there is evidence of local recurrence/metastases except localized basal skin
             cell carcinoma

          -  History/evidence of drug/alcohol abuse w/in 12 mos of Visit 1

          -  Pregnancy

          -  Any condition which may place subject at higher risk from his/her participation in the
             study or is likely to prevent subject from completing/complying w/ requirements of
             study

          -  Use of other investigational drugs and devices w/in 30 days or 5 half-lives of Visit
             1, whichever is longer

          -  History of noncompliance to medical regimens or unwillingness to comply w/ study
             protocol

          -  Any condition that would confound the evaluation/interpretation of efficacy and/or
             safety data

          -  Persons directly involved in execution of this protocol