Can HDL Infusions Significantly Quicken Atherosclerosis Regression? A phase II, Multi-center, double-blind, ascending dose, placebo-controlled, dose-finding trial of CER-001 or placebo in subjects with acute coronary syndrome.

Phase 2

Completed

Conditions: Heart Attack
Acute Coronary Syndrome
10011082

Registration Number: NL-OMON38390

Lead Sponsor: Cerenis Therapeutics SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

male or female up to and including 80 years of age, acute chest pain and diagnosis of ST segment elevation or non-ST elevation myocadial infarction or unstable angina, clincally indicated coranary angiography, evidence of coronary artery disease, and an appropriate target coronary artery.

Exclusion Criteria

Subjects weighing more than 160 kg, uncontrolled diabetes, triglycerides greater than 500 mg/dl, baseline ivus of unacceptable quality, subjects for whom CABG is planned, hemodynamically or clinically unstable, and ejcection fraction less than 35%.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for this study is the nominal change in total plaque<br /><br>volume (TPV) in a 30 mm segment of the target coronary artery assessed by<br /><br>3-dimensional (3D) IVUS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary atherosclerosis efficacy parameters will include the percent change<br /><br>in plaque volume and the change in percent atheroma volume in the target 30 mm<br /><br>segment. The percent change in plaque volume will be calculated as the nominal<br /><br>change divided by the baseline value, multiplied by 100. Percent atheroma<br /><br>(obstructive) volume will be computed by dividing plaque volume by elastic<br /><br>external membrane (EEM) volume and then multiplying by 100. Secondary<br /><br>atherosclerosis efficacy parameters will also include the change in total<br /><br>vessel volume in the target 30 mm segment; as well as changes in plaque, lumen<br /><br>and total vessel volumes from baseline to follow-up in anatomically comparable<br /><br>5 mm segments centered on the site with the smallest plaque burden at baseline,<br /><br>and the largest plaque burden at baseline on 3D IVUS. </p><br>