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 | March 2013 |
| Status | Complete |
The previous information was derived from ClinicalTrials.gov on 09/15/2015 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 | 507 patients |
The previous information was derived from ClinicalTrials.gov on 09/15/2015 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 absolute change in total plaque volume as assessed by IVUS from baseline to follow-up at 3 weeks following the final infusion of CER-001 (approximately 9 weeks following baseline measure).
Secondary Outcomes
The percent change in total plaque volume as assessed by IVUS from baseline to follow-up at 3 weeks following the final infusion of CER-001 (approximately 9 weeks following baseline measure).
Publications
- Primary Results Publication:
Results
- A total of 517 patients were randomized, of which 417 had IVUS and 461 had QCA measurements.
- Compared with placebo, there was no statistically significant difference in either the nominal or the percent total atheroma volume with any dose of CER-001.
- The incidence of major cardiovascular events (MACE) was are statistically similar across all treatment groups (8.3% (10), 13.3% (16), and 13.7% (17) in 3 mg/kg, 6 mg/kg, and 12 mg/kg CER-001 groups respectively vs. 9.8% (12) in placebo)
Conclusion
Infusion with CER-001 is not associated with a significant reduction in coronary atherosclerosis as evaluated by IVUS and QCA.