The CHI SQUARE Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: : Rim Halaby, M.D. [2]

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.

Objective

To determine the safety and efficacy of CER-001 on atherosclerotic plaque progression and regression in patients with acute coronary syndromes.

Sponsor

Cerenis Therapeutics, SA

Timeline

Timeline
Start Date	March 2011
End Date	April 2013
Status	Active, not recruiting

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01201837.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase 2
Study Design
Allocation	Randomized
Endpoint	Safety/Efficacy study
Interventional Model	Parallel Assignment
Masking	Double Blind
Study Details
Primary Purpose	Treatment
Condition	Acute Coronary Syndrome
Intervention	Drug: Placebo (weekly injection) Drug:CER-001 (weekly injection)
Study Arms	Placebo CER-001 low dose (weekly injection) CER-001 medium dose (weekly injection) CER-001 high dose(weekly injection)
Population Size	504 patients

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01201837.

Eligibility Criteria

Inclusion Criteria

• Age < 75 years
• Patients with ACS
• Angiographic evidence of CAD with suitable target coronary artery for IVUS evaluation

Exclusion Criteria

• Female of child bearing potential
• Weight > 120 kg
• Angiographic evidence of left main artery stenosis > 50%
• Uncontrolled diabetes mellitus, defined as HbA1c>10%
• Triglyceride levels > 500 mg/dL
• Symptomatic congestive heart failure with NYHA class III or IV or EF<35%
• Uncontrolled hypertension defined as SBP>180 mmHg
• Past medical history of renal disease, liver disease, metabolic disease, GI disease, or endocrine dysfunction

Outcomes

Primary Outcomes

The time frame difference in total plaque volume and absolute change in total plaque volume by intravascular ultrasound (IVUS) after 3 weeks after final dose when compared to baseline plaque volume (9 weeks after baseline evaluation).

Publications

Results

• Estimated completion rate: 75-80%
• Approximately 98 patients per group have IVUS follow-up
• Results have not been officially released

Conclusion

Pending