Functional Improvement of non-infarcT relaTed coronary artery stenosis by Extensive LDL-C Reduction with a PCSK9 Antibody.
- Conditions
- coronary artery disease (CAD)10011082
- Registration Number
- NL-OMON52478
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
- ACS with PCI of infarct related artery
- Multivessel Disease (MVD)
- FFR of non-IRA lesion: 0.67 - 0.85
- Age >= 18 years at screening
- Refusal or inability to provide informed consent
- Prior coronary artery bypass graft
- Known left ventricular ejection fraction (LVEF) < 30%
- Untreated functional left main stem stenosis (FFR <= 0.80)
- Contra-indication for antithrombotic therapy according to ESC guidelines
- Non-IRA stenosis not amenable for PCI treatment (operator*s decision)
- Complicated IRA treatment, with one or more of the following:
- Extravasation
- Permanent no re-flow after IRA treatment (TIMI flow 0-1)
- Inability to implant a stent
- Known severe cardiac valve dysfunction that will require surgery in the
follow-up period.
- Severe kidney disease defined as an eGFR < 30 ml/min.
- Known severe liver disease defined as Child-Pugh score of 10-15.
- Female subject is pregnant, breastfeeding or planning to become pregnant or
planning to breastfeed during treatment and for an additional 15 weeks after
the last dose of investigational product. Females of childbearing potential
should only be included in the study after a confirmed menstrual period and a
negative highly sensitive serum pregnancy test.
- Female subjects of childbearing potential unwilling to use 1 acceptable
method of effective contraception during treatment and for an additional 15
weeks after the last dose of investigational product.
- Female subject who has not used an acceptable method(s) of birth control for
at least 1 month prior to screening, unless the female subject is sterilized or
postmenopausal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1A. The primary physiological study endpoint is the change in FFR from baseline<br /><br>to follow-up<br /><br>in non-IRA lesions.<br /><br><br /><br>1B. The primary invasive imaging endpoint is the change in lipid core burden<br /><br>index at the<br /><br>4mm maximal segment (MaxLCBI4mm) from baseline to follow-up of the non-IRA as<br /><br>performed in sites capable of Near-InfraRed Spectroscopy (NIRS).</p><br>
- Secondary Outcome Measures
Name Time Method