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
ID
Bron
Verkorte titel
Aandoening
Cardiovascular risk
Statin intolerance
Ondersteuning
Investigator initiated research, support from Regeneron.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is the change in 18F-FDG target to background ratio (TBR) following 12 weeks of PCSK-9 inhibition
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Two weekly treatment for 12 weeks
Onderzoeksproduct en/of interventie
Placebo or Alirocumab 150 mg s.c. once every two weeks
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Increased CV-risk
Aged 50 years and older
Statin-associated muscle symptoms for at least 3 different statins
LDL-C > 100 mg/dL
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Major exclusion criteria:
CV-event in last 3 months
Diabetes Mellitus
Systemic auto-immune disease
Cancer
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6650 |
| NTR-old | NTR6884 |
| Ander register | METC AMC : 2016_321 |