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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01201837

Public ClinicalTrials.gov record NCT01201837. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01201837
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Cerenis Therapeutics, SA
Industry
Enrollment
507 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2011
Primary completion
Sep 30, 2012
Completion
Feb 28, 2013
Last update posted
Mar 2, 2014

2011 – 2013

United States locations

U.S. sites
24
U.S. states
18
U.S. cities
24
Facility City State ZIP Site status
Heart Center Research LLC Huntsville Alabama 35801
Mayo Clinic - Arizona Phoenix Arizona 85054
VA San Diego Health Care Center San Diego California 92161
Palm Beach Heart Institute, LLC - Zasa Clinical Research Boynton Beach Florida 33472
Heart and Vascular Institute of Florida Clearwater Florida 33755
Jacksonville Center for Clinical Research Jacksonville Florida 32216
Saint Joseph Research Institute Atlanta Georgia 30342
The Care Group, LLC Indianapolis Indiana 46260
Suburban Hospital Bethesda Maryland 20814
University of Michigan Health System Ann Arbor Michigan 48109
Detroit Medical Center (DMC) Cardiovascular Institute Detroit Michigan 48201
Cardiac and Vascular Research Center of Northern Michigan Petoskey Michigan 49770
Alegent Research Center Omaha Nebraska 68124
Buffalo Heart Group Buffalo New York 14215
Buffalo Cardiology & Pulmonary Associates Williamsville New York 14221
University of North Carolina Medical Center Chapel Hill North Carolina 27599
LeBauer Cardiovascular Research Foundation Greensboro North Carolina 27401
Sanford Heart Center Fargo North Dakota 58122
South Oklahoma Heart Research Oklahoma City Oklahoma 73135
Penn Presbyterian Medical Center Philadelphia Pennsylvania 19104
Sanford Research / USD Sioux Falls South Dakota 57104
Baptist Memorial Hospital Memphis Tennessee 38120
Dallas VA Medical Center Dallas Texas 75016
MultiCare Health System Research Institute / Cardiac Study Center Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01201837, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 2, 2014 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01201837 live on ClinicalTrials.gov.

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