MDCO-216 Infusions Leading to Changes in Atherosclerosis: A Novel Therapy in Development to Improve Cardiovascular Outcomes - Proof of Concept Intravascular Ultrasound (IVUS), Lipids, and Other Surrogate Biomarkers Trial

Inclusion Criteria

• Have experienced a recent ACS event within 14 days of screening that requires a clinically indicated coronary angiogram.
• A qualifying ACS event will be defined as follows: a diagnosis of a qualifying myocardial infarction (MI) event will be defined by abnormal levels of cardiac biomarkers (troponin I or T or creatine kinase myoglobin [CK-MB] mass) with at least one determination greater than the 99th percentile or upper limits of normal (ULN) for the laboratory and at least one of the following: chest discomfort or symptoms of myocardial ischemia (≥10 minutes) at rest within 24 hours prior to hospitalization for MI and/or new electrocardiogram (ECG) findings (or presumed new if no prior ECG available) indicative of acute myocardial ischemia in absence of left ventricular hypertrophy (LVH) and left bundle branch block (LBB).
• Baseline coronary angiogram must meet all of the following criteria for IVUS interrogation of target artery:
• Target artery must be accessible to the IVUS catheter
• Target artery must have a stenotic area of ≥20% and 180 millimeters of mercury (mmHg) or diastolic blood pressure >110 mmHg prior to randomization despite anti-hypertensive therapy.
• Poorly controlled diabetes mellitus and a hemoglobin A1c (HbA1c) >10.0% prior to randomization.
• Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or alanine aminotransferase, aspartate aminotransferase elevation >2 x ULN or total bilirubin elevation >1.5 x ULN at screening confirmed by a repeat measurement at least one week apart.
• Fasting triglyceride value >400 milligrams/deciliter (mg/dL).
• Impaired kidney function defined as calculated glomerular filtration rate 3 years before screening.
• Body weight >120 kg.
• Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal litigation). Women who are >2 years postmenopausal defined as ≥1 year since last menstrual period and are <55 years old with a negative pregnancy test within 24 hours of randomization or surgically sterile are exempt from this exclusion.
• Males who are unwilling to use an acceptable method of birth control during the entire study period (such as, condom with spermicide).
• Previous participation (enrollment and randomization) in this study or any preceding study with ETC-216 (predecessor compound of MDCO-216), MDCO-216, or similar investigational medicines containing apolipoprotein A-I (ApoA-I) proteins.
• Known allergy to the phospholipid or any other component of the investigational product (dimeric recombinant ApoA-IM, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, or mannitol and sucrose in phosphate buffer).
• Treatment with other investigational medicinal products or devices within 30 days or 5 half˗lives, whichever is longer.
• Known history of alcohol and/or drug abuse.
• Use of other investigational medicinal products or devices during the course of the study, excluding Post-Marketing Registries.
• Any condition that according to the investigator could interfere with the conduct of the study.