Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cerenis Therapeutics, SA
With
South Australian Health and Medical Research Institute
Subjects will be required to have at least one epicardial coronary artery suitable for IVUS imaging. A suitable target artery for IVUS imaging will be determined at baseline as having stenosis of up to 50% and meeting all angiographic inclusion criteria. Subjects having met all eligibility criteria will be randomized to receive an intravenous infusion of CER 001 (3 mg/kg) or placebo within 14 days of event presentation. Randomized subjects will then return at 7 day intervals for nine additional infusions. A follow up IVUS will be conducted at 14 days after the last infusion. The total study duration from randomization to follow up IVUS for a completed study can range from approximately 9 to 12 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female greater than 18 years of age
Acute coronary syndrome (myocardial infarction or unstable agina)
Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation
You may not be if
Females of child-bearing potential
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
