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

Phase 2
Completed
Conditions
Acute Coronary Syndrome
Interventions
Drug: Placebo
Registration Number
NCT01201837
Lead Sponsor
Cerenis Therapeutics, SA
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
507
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High DoseCER-001CER-001 High Dose
PlaceboPlacebo-
Mid DoseCER-001CER-001 Mid Dose
Low DoseCER-001CER-001 Low Dose
Primary Outcome Measures
NameTimeMethod
Change in Total Plaque VolumeBaseline 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
NameTimeMethod
Percent Change in Plaque VolumeBaseline 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)

Trial Locations

Locations (47)

Heart Center Research LLC

🇺🇸

Huntsville, Alabama, United States

Mayo Clinic - Arizona

🇺🇸

Phoenix, Arizona, United States

VA San Diego Health Care Center

🇺🇸

San Diego, California, United States

Palm Beach Heart Institute, LLC - Zasa Clinical Research

🇺🇸

Boynton Beach, Florida, United States

Heart and Vascular Institute of Florida

🇺🇸

Clearwater, Florida, United States

Jacksonville Center for Clinical Research

🇺🇸

Jacksonville, Florida, United States

Saint Joseph Research Institute

🇺🇸

Atlanta, Georgia, United States

The Care Group, LLC

🇺🇸

Indianapolis, Indiana, United States

Suburban Hospital

🇺🇸

Bethesda, Maryland, United States

University of Michigan Health System

🇺🇸

Ann Arbor, Michigan, United States

Scroll for more (37 remaining)
Heart Center Research LLC
🇺🇸Huntsville, Alabama, United States

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