Acute Coronary Syndrome
Conditions
Keywords
Acute coronary syndrome, HDL mimetic, ApoA-I
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 management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).
Interventions
DRUGPlacebo
Weekly injection
DRUGCER-001
Weekly injection
Sponsors
Cerenis Therapeutics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Plaque Volume | Baseline and 3 weeks post final dose | Absolute change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken \ 3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Plaque Volume | Baseline and 3 weeks post final dose | Percent change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken \ 3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment) |
Countries
Canada, France, Netherlands, United States
Outcome results
None listed