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]; Yazan Daaboul, M.D.

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.

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 (once-weekly injection) for 6 weeks
Drug: CER-001 (once-weekly injection) for 6 weeks
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 and QCA. The change is measured from baseline to follow-up at 3 weeks (2-5 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 and QCA. The change is measured from baseline to follow-up at 3 weeks (2-5 weeks) following the final infusion of CER-001 (approximately 9 weeks following baseline measure).

Publications

  • Primary Results Publication:
Tardif JC, Ballantyne CM, Barter P, et al. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial. Eur Heart J. 2014;35(46):3277-86.

Results

  • A total of 507 patients were randomized, of which 417 had IVUS and 461 had QCA measurements.[1]
  • 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.[1]
  • The incidence of major cardiovascular events (MACE) was statistically similar across all treatment groups (8.3% (10), 13.3% (16), and 13.7% (17) in the 3 mg/kg, 6 mg/kg, and 12 mg/kg CER-001 groups respectively vs. 9.8% (12) in placebo).[1]

Conclusion

Infusion with CER-001 is not associated with a significant reduction in coronary atherosclerosis as evaluated by IVUS and QCA.[1]

References

  1. 1.0 1.1 1.2 1.3 Tardif JC, Ballantyne CM, Barter P, Dasseux JL, Fayad ZA, Guertin MC; et al. (2014). "Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial". Eur Heart J. 35 (46): 3277–86. doi:10.1093/eurheartj/ehu171. PMC 4258222. PMID 24780501.