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 - CHI SQUARE

• Conditions: Symptoms of Acute Coronary Syndrome; MedDRA version: 12.1Level: LLTClassification code 10051592Term: Acute coronary syndrome; MedDRA version: 12.1Level: PTClassification code 10051592Term: Acute coronary syndrome

• Registration Number: EUCTR2010-023611-34-NL
• Lead Sponsor: Cerenis Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-03
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Male or female under 75 years of age, acute chest pain and diagnosis of ST segment elevation or non-ST elevation myocardial infarction or unstable angina, clinically indicated coronary angiography, evidence of coronary artery disease, and an appropriate target coronary artery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects weighing more than 120 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 ejection fraction less than 35%.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or Placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.;Secondary Objective: None;Primary end point(s): The nominal change in total plaque volume in a 30 mm segment of the target coronary artery assessed by 3-dimensional IVUS.