CER-001 Atherosclerosis Regression ACS Trial (CARAT)

Cerenis Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndromes

Treatments: Drug: Placebo; Drug: CER-001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02484378

CER-001-CLIN-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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301 participants in 2 patient groups, including a placebo group

CER-001

Experimental group

Description:

CER-001 infusion

Treatment:

Drug: CER-001

Placebo

Placebo Comparator group

Description:

Placebo infusion

Treatment:

Drug: Placebo