Trial | NCT01201837  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cer-001 ...

  • Study Participants

    507
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).
Study Started
Mar 31
2011
Primary Completion
Oct 31
2012
Study Completion
Mar 31
2013
Last Update
Mar 03
2014
Estimate

Drug Placebo

Weekly injection

Drug CER-001

Weekly injection

Placebo Placebo Comparator

Low Dose Experimental

CER-001 Low Dose

Mid Dose Experimental

CER-001 Mid Dose

High Dose Experimental

CER-001 High Dose

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
No Results Posted