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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
507

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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