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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20315

Enrollment

Registered

2017-12-08

Start date

2017-05-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular risk Statin intolerance

Interventions

Placebo or Alirocumab 150 mg s.c. once every two weeks

Eligibility

Inclusion criteria

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

Exclusion criteria: Major exclusion criteria: CV-event in last 3 months Diabetes Mellitus Systemic auto-immune disease Cancer

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change in 18F-FDG target to background ratio (TBR) following 12 weeks of PCSK-9 inhibition	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactR.M. Hoogeveen

AMC

r.m.hoogeveen@amc.uva.nl020-5668061

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)