A PHASE II MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FOCUSING TRIAL OF CER-001 IN SUBJECTS WITH ACUTE CORONARY SYNDROME
- Conditions
- Acute Coronary Syndrome (ACS) with significant plaque volumeTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-001381-26-NL
- Lead Sponsor
- CERENIS THERAPEUTICS SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 292
1. Subjects must provide informed consent, as approved by the IRB/EC prior to performance of any screening procedures
2. Male or female at least 18 years of age
3. Subject of non child-bearing potential,
a) Greater than 12 months since last menstrual period; and/or surgically sterilized and agree to use barrier method of birth control for the entire study; and/or
b) On hormonal therapy (including implants, injections, combined oral contraceptives and IUDs) and agree to use a barrier method of birth control for the entire study: and/or
c) Agree to use a double barrier method of birth control defined as condom in combination with diaphragm, contraceptive sponge, spermicidal foam or cervical cap.
4. Subjects who undergo coronary angiography within 7 days of presentation with ACS:
ACS Criteria Myocardial Infarction
a) Cardiac biomarkers (troponin I or T, CKMB mass, or CK-MB activity) with at least one determination > 99th percentile or above the local laboratory upper reference limit
AND one of the following:
b) Chest pain or ischemic symptoms at rest >10 minutes within prior 24 hours
c) New ECG changes of acute ischemia (LBBB, ST elevations, or ST depressions)
d) New pathologic Q-waves or R/S >1 in V1- V2
e) Regional myocardial scar or ischemia by nuclear, magnetic resonance, echocardiographic, or angiographic imaging
OR Biomarker-Negative ACS (Unstable Angina)
a) No elevation of cardiac biomarkers
b) Chest pain or ischemic symptoms at rest >10 minutes
c) Prompting Hospitalization or chest pain observation unit within 24 hours of symptoms
AND one of the following:
d) New or worsening ECG changes (transient ST elevation, ST depression, or T inversion)
e) Definite myocardial ischemia on nuclear or echocardiographic imaging
f) Angiographic stenosis >70% or thrombus in epicardial coronary artery or bypass graft and/or performance of PCI
5. Baseline Coronary angiogram must meet all the following criteria for IVUS interrogation of Target Artery;
Target Artery:
a) Must be accessible to the IVUS catheter
b) Must have a stenotic area of =50% in lumen diameter by angiographic visual estimation within the length of the native coronary artery for imaging by IVUS
c) The target artery may not be a bypass graft
d) The target artery may not be the culprit vessel for a previous MI
Target Artery May Have:
a) A lesion up to 60% stenosis, distal to the target segment, provided that this area is not anticipated to be a target for PCI or CABG during the course of the study
b) A single branch of the target artery may have a narrowing =70% by visual estimation, provided that the branch is not a target for PCI or CABG during the course of the study
6. Subject is able to be randomized within 14 days of ACS event presentation
7. Baseline IVUS interrogation determined to be of acceptable quality with PAV = 30% in the proximal 10mm at review by the Imaging Core Lab
8. Subject must be willing to participate in the study and comply with all protocol requirements, including willingness to:
a) Return to the clinic weekly for a total of ten IV infusions of study drug
b) Return to the clinic for follow up visits
c) Return to the clinic at the end of the study for follow up IVUS procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58
1. Baseline IVUS not completed due to non-qualifying coronary angiogram as demonstrated by:
a) Greater than 50% reduction in lumen of the left main coronary artery by visual estimation
b) Extensive coronary artery disease with no target vessel for IVUS interrogation
c) Angiographically normal coronary arteries
2. Baseline IVUS interrogation determined to be unacceptable by the Imaging Core Lab
3. Subjects with uncontrolled diabetes defined as HbA1c > 10% at Screening
4. Subjects with triglycerides >500 mg/dL at Screening
5. Subjects with coronary artery bypass graft (CABG) surgery in previous 6 weeks or in whom CABG is planned
6. Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization
7. Subjects who have symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV) at baseline
8. Subjects with a known ejection fraction <35% (investigations to document EF not required)
9. Subjects with clinically significant valvular heart disease likely to require surgical repair or replacement during the treatment period of the study
10. Subject is hemodynamically or clinically unstable in the opinion of the Investigator.
11. Subject has uncontrolled hypertension (e.g., sitting systolic BP > 180 mm Hg on antihypertensive therapy) at time of randomization
12. Subject has known major hematologic, hepatic (liver enzymes greater than twice the upper limits of normal for the performing laboratory), metabolic, gastrointestinal or endocrine dysfunction in the judgment of the Investigator
13. Subject has known renal dysfunction CrCl = =30mL/min
14. Any clinically significant medical condition or presence of any laboratory abnormality performed prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study
15. Subject is likely to be unreliable as a study participant based on the Investigator's (or designee’s) knowledge of the subject (e.g., alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
16. Subject has participated in any investigational drug or interventional device study within 30 days prior to randomization, or expects to participate in any other investigational drug or interventional device study during his/her planned participation in this study
17. Subject has previously participated in this study or another study involving CER-001.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method