Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02678923 | 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 | PHASE1 | COMPLETED | 126 | — | — | Dec 3, 2015 | Oct 26, 2016 | Jul 13, 2017 | 20 | Canada, Czechia +3 |
Change from Baseline to Day 36 post-randomization in PAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in PAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline PAV as a covariate and treatment group as factor. Least Squares (LS) mean was adjusted for stratification factors of country and prior statin use.
| Arm | Type | Description |
|---|---|---|
| MDCO-216 | EXPERIMENTAL | 20 mg/kg of MDCO-216 administered intravenously (IV) as a 360 milliliter (mL) infusion over 2 hours on Days 1, 8, 15, 22, and 29 |
| Placebo | PLACEBO_COMPARATOR | 360 mL of placebo (0.9% sodium chloride \[NaCl\] solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29 |
| Name | Type | Description |
|---|---|---|
| MDCO-216 | DRUG | - |
| Placebo | DRUG | - |
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 card...