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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

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).

Key facts

Study ID

NCT01201837

Run by

Cerenis Therapeutics, SA

People needed

507

Starts

2011-03-01

Expected to finish

2013-03-01

Last updated by the study team

2014-03-03

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Detroit Medical Center (DMC) Cardiovascular Institute — Detroit, Michigan, United States
• Cardiac and Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States
• Alegent Research Center — Omaha, Nebraska, United States
• Buffalo Heart Group — Buffalo, New York, United States
• Buffalo Cardiology & Pulmonary Associates — Williamsville, New York, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• LeBauer Cardiovascular Research Foundation — Greensboro, North Carolina, United States
• Sanford Heart Center — Fargo, North Dakota, United States
• South Oklahoma Heart Research — Oklahoma City, Oklahoma, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Sanford Research / USD — Sioux Falls, South Dakota, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• MultiCare Health System Research Institute / Cardiac Study Center — Tacoma, Washington, United States
• Foothills Medical Centre — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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