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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201837
First Posted: September 15, 2010
Last Update Posted: March 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cerenis Therapeutics, SA
  Purpose
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).

Condition Intervention Phase
Acute Coronary Syndrome Drug: Placebo Drug: CER-001 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cerenis Therapeutics, SA:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 507
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201837


  Show 47 Study Locations
Sponsors and Collaborators
Cerenis Therapeutics, SA
Investigators
Principal Investigator: Jean-Claude Tardif, MD Montreal Heart Institute
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cerenis Therapeutics, SA
ClinicalTrials.gov Identifier: NCT01201837     History of Changes
Other Study ID Numbers: CER-001-CLIN-002
First Submitted: September 13, 2010
First Posted: September 15, 2010
Last Update Posted: March 3, 2014
Last Verified: January 2014

Keywords provided by Cerenis Therapeutics, SA:
Acute coronary syndrome
HDL mimetic
ApoA-I

Additional relevant MeSH terms:
Syndrome
Atherosclerosis
Acute Coronary Syndrome
Disease
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases