The CHI SQUARE Trial: Difference between revisions
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==Sponsor== | ==Sponsor== | ||
Cerenis | Cerenis Therapeutics, SA | ||
==Timeline== | ==Timeline== | ||
Revision as of 20:31, 19 September 2013
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High Density Lipoprotein Microchapters |
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Treatment |
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Clinical Trials |
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The CHI SQUARE Trial On the Web |
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American Roentgen Ray Society Images of The CHI SQUARE Trial |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
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 |
| Run-In Period | 2 years |
| End Date | April 2013 |
| Status | Active, not recruiting |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT------.
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 | Approximately 504 patients of both genders; and approximately 126 patients per group |
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
Objective
To determine the safety and efficacy of CER-001 on atherosclerotic plaque progression and regression in patients with acute coronary syndromes.
Timeline
Start Date
March 2011
End Date for Final Data Collection for Primary Outcomes
December 2012
Study Completion Date
April 2013
Methods
- Phase II Study
- A 5 week multicenter, double-blinded, ascending dose, placebo-controlled, dose-finding clinical trial followed by 2-5 week observational period, and long-term follow-up up to 6 months.
- Data from CER-001-CLIN-001 showed that single intravenous infusion of CER-001 at doses up to 45 mg/kg over 1-2 hours is effect, safe, and tolerated.
- Estimated enrollment: Approximately 504 patients of both genders; and approximately 126 patients per group.
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.
Study Arms
- Placebo weekly injection
- CER-001 low dose weekly injection
- CER-001 mid dose weekly injection
- CER-001 high dose weekly injection
Patients undergo 6 injections in 5 weeks of therapy period. During 2-5 week observation period, patients are followed-up by an interim visit and by later follow-up IVUS visit at end of observational period. Finally, patients will visit after 6 months of observation period end for a final follow-up visit.
Outcomes
Primary Outcome
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).
Results
- Estimated completion rate: 75-80%
- Approximately 98 patients per group have IVUS follow-up
- Results have not been officially released
Conclusion
Pending