CER-001 Atherosclerosis Regression ACS Trial; A Phase II Multi-Center, Double-Blind, Placebo-Controlled, Dose-Focusing Trial Of Cer-001 In Subjects With Acute Coronary Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 301
- Locations
- 35
- Primary Endpoint
- Nominal Change in Percent Atheroma Volume (PAV)
Study Overview
Brief Summary
The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary IVUS, when administered to subjects presenting with Acute Coronary Syndrome (ACS) with significant plaque volume.
Detailed Description
Subjects will be required to have at least one epicardial coronary artery suitable for IVUS imaging. A suitable target artery for IVUS imaging will be determined at baseline as having stenosis of up to 50% and meeting all angiographic inclusion criteria. Subjects having met all eligibility criteria will be randomized to receive an intravenous infusion of CER 001 (3 mg/kg) or placebo within 14 days of event presentation. Randomized subjects will then return at 7 day intervals for nine additional infusions. A follow up IVUS will be conducted at 14 days after the last infusion. The total study duration from randomization to follow up IVUS for a completed study can range from approximately 9 to 12 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female greater than 18 years of age
- •Acute coronary syndrome (myocardial infarction or unstable agina)
- •Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation
Exclusion Criteria
- •Females of child-bearing potential
- •Angiographic evidence of >50% stenosis of the left main artery
- •Uncontrolled diabetes (HbA1C>10%)
- •Hypertriglyceridemia (>500 mg/dL)
- •Congestive heart failure (NYHA class III or IV)
- •Ejection fraction <35%
- •Uncontrolled hypertension (SBP >180 mm Hg)
- •Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
Arms & Interventions
CER-001
CER-001 infusion
Intervention: CER-001 (Drug)
Placebo
Placebo infusion
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Nominal Change in Percent Atheroma Volume (PAV)
Time Frame: Baseline to 12 weeks
The nominal change from baseline to follow-up (at 12 weeks) in the percent atheroma volume (PAV) in the target coronary artery assessed by 3 dimensional (3D) IVUS
Secondary Outcomes
- Nominal Change in Normalized Total Atheroma Volume (TAV)(Baseline to 12 weeks)