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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02586155 | Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD | PHASE3 | COMPLETED | 2,425 | — | — | Nov 1, 2015 | Jun 21, 2021 | Aug 20, 2021 | 214 | Argentina, Australia +13 |
Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
| Arm | Type | Description |
|---|---|---|
| High-Intensity statin therapy+RVX000222 | EXPERIMENTAL | Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) |
| High-Intensity statin therapy+Placebo | ACTIVE_COMPARATOR | Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) |
| Name | Type | Description |
|---|---|---|
| Apabetalone | DRUG | 100 mg capsule |
| Placebo | DRUG | Capsule manufactured to mimic RVX000222 100 mg capsule |
| Atorvastatin | DRUG | High-Intensity Statin |
| Rosuvastatin | DRUG | High-Intensity Statin |
Inclusion Criteria: • ACS 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 a...