A Phase 2 interventional study of Placebo and CER-001 in Acute Coronary Syndrome, sponsored by Cerenis Therapeutics, SA. Completed at 47 sites in 4 countries. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2014-03-03.
Sponsored by Cerenis Therapeutics, SA · Phase 2, Interventional, and Treatment
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).
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 507 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Cerenis Therapeutics, SA is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
CER-001 Low Dose
Drug: CER-001
CER-001 Mid Dose
Drug: CER-001
CER-001 High Dose
Drug: CER-001
Weekly injection
Weekly injection
Change in Total Plaque Volume
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)
Time frame: Baseline and 3 weeks post final dose
Percent Change in Plaque Volume
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)
Time frame: Baseline and 3 weeks post final dose
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Cerenis Therapeutics, SA