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

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	9/23/2012
Start Date:	March 2011
End Date:	October 2012
Contact:	CHI-SQUARE Project Manager MHICC
Email:	Benoit.Pronovost@mhicc.org
Phone:	514-461-1300

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).

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

We found this trial at

sites

Johns Hopkins Hospital

1800 Orleans St.
Baltimore, Maryland 21287

410-955-5000