The CHI SQUARE Trial: Difference between revisions
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===Study Completion Date=== | ===Study Completion Date=== | ||
April 2013 | April 2013 | ||
==Methods== | |||
==Methods== | |||
*Phase II Study | *Phase II Study | ||
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*Estimated enrollment: Approximately 504 patients of both genders; and approximately 126 patients per group. | *Estimated enrollment: Approximately 504 patients of both genders; and approximately 126 patients per group. | ||
Inclusion criteria | ===Inclusion criteria=== | ||
*Age < 75 years | |||
*Patients with ACS | |||
*Angiographic evidence of CAD with suitable target coronary artery for IVUS evaluation. | |||
Exclusion criteria | ===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, pts will visit after 6 months of observation period end for a final follow-up visit | 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, pts will visit after 6 months of observation period end for a final follow-up visit | ||
Revision as of 01:22, 19 September 2013
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Diagnosis |
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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]
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
Final Data Collection for Primary Outcomes End Date
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, pts will visit after 6 months of observation period end for a final follow-up visit
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Results
Pending
Conclusion
Pending