Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial (CHI SQUARE)

January 29, 2014 updated by: Cerenis Therapeutics, SA

CHI SQUARE: 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

Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

507

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Heart Institute Foundation
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • St. John Health Center
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Center
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Centre de santé et de services sociaux de Laval
      • Montreal, Quebec, Canada, H1T1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital Research Institute
      • St-Charles-Borromée, Quebec, Canada, J6E 6J2
        • CSSS du Nord de Lanaudière
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Centre Hospitalier Regional de Trois-Rivieres
  • France
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Toulouse, France
        • Centre Hospitalier Universitaire de Toulouse Rangueil
    • PESSAC Cedex
      • Bordeaux, PESSAC Cedex, France, 33064
        • Hôpital Cardiologique du Haut-Lévesque
  • Netherlands
    • AC
      • Amsterdam, AC, Netherlands, 1091
        • Onze Lieve Vrouwe Gasthius
    • AD
      • Leeuwarden, AD, Netherlands, 8934
        • Medisch Centrum Leeuwarden
    • AZ
      • Amsterdam, AZ, Netherlands, 1105
        • Academic Medical Center
    • Amsterdam
      • Alkmaar, Amsterdam, Netherlands, JD 1815
        • Medisch Centrum Alkmaar
    • CM
      • Nieuwegein, CM, Netherlands, 3430
        • St. Antonius Ziekenhuis Nieuwegein
    • DZ
      • Rotterdam, DZ, Netherlands, 3079
        • Maassstadziekenhuis Cardiology Research
    • EJ
      • Eindhoven, EJ, Netherlands, 5623
        • Catharina Ziekenhuis Eindhoven
    • ER
      • Enschede, ER, Netherlands, 7513
        • Medisch Spectrum Twente
    • SZ
      • Nijmegen, SZ, Netherlands, 6532
        • Canisius Wilhelmina Ziekenhuis
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research LLC
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Arizona
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Health Care Center
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Palm Beach Heart Institute, LLC - Zasa Clinical Research
      • Clearwater, Florida, United States, 33755
        • Heart and Vascular Institute of Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • The Care Group, Llc
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Suburban Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center (DMC) Cardiovascular Institute
      • Petoskey, Michigan, United States, 49770
        • Cardiac and Vascular Research Center of Northern Michigan
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Alegent Research Center
    • New York
      • Buffalo, New York, United States, 14215
        • Buffalo Heart group
      • Williamsville, New York, United States, 14221
        • Buffalo Cardiology & Pulmonary Associates
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Medical Center
      • Greensboro, North Carolina, United States, 27401
        • LeBauer Cardiovascular Research Foundation
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Heart Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Research / USD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
    • Texas
      • Dallas, Texas, United States, 75016
        • Dallas VA Medical Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System Research Institute / Cardiac Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female less than 75 years of age
  • Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina)
  • Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation

Exclusion Criteria:

  • Females of child-bearing potential
  • Weight >120 kg
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Weekly injection
EXPERIMENTAL: Low Dose
CER-001 Low Dose
Drug: CER-001
Weekly injection
EXPERIMENTAL: Mid Dose
CER-001 Mid Dose
Drug: CER-001
Weekly injection
EXPERIMENTAL: High Dose
CER-001 High Dose
Drug: CER-001
Weekly injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Plaque Volume
Time Frame: Baseline and 3 weeks post final dose
Absolute change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken ~3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment)
Baseline and 3 weeks post final dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Plaque Volume
Time Frame: Baseline and 3 weeks post final dose
Percent change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken ~3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment)
Baseline and 3 weeks post final dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerenis Therapeutics, SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (ESTIMATE)

September 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-001-CLIN-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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