CER-001 Atherosclerosis Regression ACS Trial

Phase 2

Completed

• Conditions: Acute Coronary Syndromes
• Interventions: Drug: Placebo; Drug: CER-001

• Registration Number: NCT02484378
• Lead Sponsor: Cerenis Therapeutics, SA

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 Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-29
• Study Start: 2015-08
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2017-01
• Disposition First Submitted: 2019-02-06
• Disposition First Submitted QC: 2019-02-06
• Last Update Submitted: 2019-02-06
• Disposition First Posted: 2019-02-11
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo infusion
CER-001	CER-001	CER-001 infusion

Primary Outcome Measures

Name	Time	Method
Nominal Change in Percent Atheroma Volume (PAV)	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 Outcome Measures

Name	Time	Method
Nominal Change in Normalized Total Atheroma Volume (TAV)	Baseline to 12 weeks

Trial Locations

Locations (35)

Heart Center Research, LLC; 🇺🇸 Huntsville, Alabama, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

VA Eastern Colorado Health Care System; 🇺🇸 Denver, Colorado, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Cardiovascular Associates Research LLC; 🇺🇸 Covington, Louisiana, United States

Cardiac and Vascular Research Center of Northern Michigan; 🇺🇸 Petoskey, Michigan, United States

University of Missouri Health System; 🇺🇸 Columbia, Missouri, United States

Buffalo Heart Group LLP; 🇺🇸 Buffalo, New York, United States

Veterans Affairs WNY Healthcare System; 🇺🇸 Buffalo, New York, United States

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