CER-001 Atherosclerosis Regression ACS Trial

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerenis Therapeutics, SA
• Collaborator: South Australian Health and Medical Research Institute

Criteria

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