No registrations found.
ID
Source
Brief title
Health condition
Cardiovascular risk
Statin intolerance
Sponsors and support
Investigator initiated research, support from Regeneron.
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in 18F-FDG target to background ratio (TBR) following 12 weeks of PCSK-9 inhibition
Secondary outcome
The secondary endpoints are the difference in inflammatory parameters before and
after PCSK-9 inhibition and to evaluate whether there is a correlation between 18F-FDG PET
activity in arterial wall and circulating inflammatory markers
Background summary
This is a multi-center, double-blind, placebo-controlled, intervention study in 50 subjects using PCSK9 inhibition in patients with increased CV-risk and statin intolerance. The primary endpoint is the change in 18F-FDG target-to-background ratio (TBR) following 12 weeks of treatment.
Study objective
To assess the change in arterial wall inflammation, measured with 18F-FDG PET/CT, in patients
with increased CV-risk and statin intolerance due to statin-associated muscle symptoms after PCSK9 inhibition
Study design
Two weekly treatment for 12 weeks
Intervention
Placebo or Alirocumab 150 mg s.c. once every two weeks
Inclusion criteria
Increased CV-risk
Aged 50 years and older
Statin-associated muscle symptoms for at least 3 different statins
LDL-C > 100 mg/dL
Exclusion criteria
Major exclusion criteria:
CV-event in last 3 months
Diabetes Mellitus
Systemic auto-immune disease
Cancer
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL6650 |
| NTR-old | NTR6884 |
| Other | METC AMC : 2016_321 |