Arterial wall inflammation measured with 18F-FDG PET/CT in patients with statin intolerance before and after treatment with a PCSK-9 inhibitor

Phase 1

Conditions: Patients with CV-risk and statin intolerance due to statin-associated muscle symptoms (SAMS)
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-004794-41-NL

Lead Sponsor: Academical medical centre, dep of internal medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Increased CV-risk
oClinical diagnosis of Familial Hypercholesterolemia, OR
oPrevious CV-event, OR
oImaging (CT, MRI, Angiography) compatible with atherosclerotic disease, OR
o(very) high CV risk estimated by risk-engines (Framingham, Score, Procam)
•Aged 50 years or older
•Statin-associated Muscle symptoms (SAMS) for at least 3 different statins, precluding statin use
•LDL-C > 100 mg/dL

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Previous CV-event within 3 months prior to study screening visit
• Malignant disease in past five years or any medical condition that could interfere with the conduct of the study in the opinion of the investigator.
• Use of any dose of any statin
• Chronic or recent (<1 month) infections and/or clinical signs of acute infection
and/or CRP>10 mg/L
• Auto-immune diseases
• Use of chronic immunosuppressant or antibiotics in the last 6 weeks
•Standard contra-indications to 18F-FDG PET/CT based on physicians experience and current practices
• Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
•Participation in a scientific study with radiation exposure in the year prior to inclusion.