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

Cerenis Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: CER-001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01201837

CER-001-CLIN-002

Details and patient eligibility

About

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).

Enrollment: 507 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

507 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Low Dose

Experimental group

Description:

CER-001 Low Dose

Treatment:

Drug: CER-001

Mid Dose

Experimental group

Description:

CER-001 Mid Dose

Treatment:

Drug: CER-001

High Dose

Experimental group

Description:

CER-001 High Dose

Treatment:

Drug: CER-001