To assess the impact of 10 intravenous infusions of 3 mg/kg CER-001 versus placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS, when administered to subjects presenting with an ACS event.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline to follow-up in the percent atheroma volume in the target
coronary artery assessed by 3D IVUS.
Secondary outcome
Change from baseline to follow-up in total atheroma volume (TAV) and change in
TAV in the 10-mm sub segment of the coronary artery with the largest plaque
volume at baseline. Adverse events.
Background summary
Despite the availability of several classes of very effective drugs,
dyslipidemia and risk factor control are poorly served and there remains a
large unmet medical need for new, effective and well tolerated therapies. There
are a number of therapies given on a chronic basis to reduce long term risk,
but subjects are at the highest risk immediately after an acute event. There is
a high need for acute therapies which can be given at, or near, the time of an
event, that will lead to rapid pacification of unstable plaque.
CER-001 negatively charged lipoprotein complex mimicking natural HDL,
consisting of a combination of two naturally occurring phospholipids and
recombinant human apolipoproteinA-I (apoA-I).
The primary aim of this study is to assess the impact of 10 intravenous
infusions of 3 mg/kg CER-001 versus placebo on atherosclerotic plaque volume,
as measured by coronary IVUS, when administered to subjects presenting with an
Acute Coronary Syndrome (ACS) event.
Study objective
To assess the impact of 10 intravenous infusions of 3 mg/kg CER-001 versus
placebo, given at weekly intervals, on atherosclerotic plaque volume, as
measured by coronary IVUS, when administered to subjects presenting with an ACS
event.
Study design
Randomized double-blind phase II parallel group study. Randomization (1:1) to:
• CER-001 3 mg/kg (10 weekly infusions in 30 minutes);
• Placebo infusions (normal saline).
At baseline subjects will be required to have at least one epicardial coronary
artery suitable for IVUS imaging.
Randomization within 14 days of the ACS event.
IVUS imaging at baseline and 14 days after the end of treatment.
Study duration approx. 12 weeks (range 53-103 days).
600 screened, 292 randomized subjects.
If needed (because of condition of de subject or urgent need for
interventions), the informed consent procedure at baseline may be reduced to
the minimum: a 1+ page ICF and the most important questions. If needed the
subject may give a verbal consent in the presence of a next of kin or
independent witness, who will sign the consent form. After pacification of the
situation/subject*s condition, the full written en verbal part of the consent
procedure will take place, including signing the consent form when the subject
has decided to proceed with the study.
Intervention
Treatment with CER-001 or placebo on top of regular treatment.
Study burden and risks
Risk: adverse events of study treatment.
Burden:
Visits: 12 visits (some will take place before discharge from hospital) in
approx. 12 weeks.
Physical examination; twice.
Blood tests: 12 times (fasting) , 20-40 mL/occasion.
Urine tests: twice.
ECG: twice.
Cardiac catheterization (for study purposes only): once (after the end of study
treatment).
IVUS (for study purposes): twice.
Rue de la Découverte 265
Labege 31670
FR
Rue de la Découverte 265
Labege 31670
FR
Listed location countries
Age
Inclusion criteria
• Males and females, 18 years and above.
• Subjects who undergo coronary angiography within 7 days of presentation with ACS. Criteria for myocardial infarction and unstable angina see protocol page 6.
• Admission criteria for baseline coronary angiogram related to IVUS. See protocol page 7 for details.
• Randomization within 14 days of ACS presentation.
• Baseline IVUS completed and of acceptable quality.
• Females of childbearing potential: hormonal contraception or double barrier method during study.
Exclusion criteria
• Uncontrolled diabetes defined as HbA1c > 10% at screening.
• Triglycerides >500 mg/dL at screening.
• Coronary artery bypass graft surgery in previous 6 weeks or planned.
• Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization.
• Heart failure NYHA class III or IV.
• Ejection fraction <35%.
• Renal dysfunction CrCl <=30 ml/min.
• Participation in any investigational drug or interventional device study within 30 days.
• Participation in another CER-001 trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov; registratienummer n.n.b. |
| EudraCT | EUCTR2015-001381-26-NL |
| CCMO | NL53502.100.15 |