Status:
COMPLETED
Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial
Lead Sponsor:
Cerenis Therapeutics, SA
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term m...
Eligibility Criteria
Inclusion
- Male or female less than 75 years of age
- Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina)
- Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation
Exclusion
- Females of child-bearing potential
- Weight \>120 kg
- Angiographic evidence of \>50% stenosis of the left main artery
- Uncontrolled diabetes (HbA1C\>10%)
- Hypertriglyceridemia (\>500 mg/dL)
- Congestive heart failure (NYHA class III or IV)
- Ejection fraction \<35%
- Uncontrolled hypertension (SBP \>180 mm Hg)
- Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT01201837
Start Date
March 1 2011
End Date
March 1 2013
Last Update
March 3 2014
Active Locations (47)
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1
Heart Center Research LLC
Huntsville, Alabama, United States, 35801
2
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
3
VA San Diego Health Care Center
San Diego, California, United States, 92161
4
Palm Beach Heart Institute, LLC - Zasa Clinical Research
Boynton Beach, Florida, United States, 33472