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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerenis Therapeutics, SA
ClinicalTrials.gov Identifier:
NCT01201837
First received: September 13, 2010
Last updated: January 29, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201837

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

Publications:

Responsible Party: Cerenis Therapeutics, SA
ClinicalTrials.gov Identifier: NCT01201837     History of Changes
Other Study ID Numbers: CER-001-CLIN-002
Study First Received: September 13, 2010
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Atherosclerosis
Acute Coronary Syndrome
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014