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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45376

Enrollment

Registered

2017-02-13

Start date

2017-04-20

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

arterial wall thickening Atherosclerosis

Interventions

Treatment with Alirocumab (or placebo) for 3 months.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged 50 years or older. With Statin-associated Muscle symptoms (SAMS) and Increased cardiovascular risk with high LDL-cholesterol.

Exclusion criteria

Exclusion criteria: - Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. - Chronic or recent (10 - Auto-immune diseases - Recent or chronic immunosuppresant / antibiotic usage - Diabetes (type 1/ type 2) - Standard contra-indications to 18F-FDG PET/CT based on psysicians experience and current practice.

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 hematopoietic 18F-FDG activity in bone marrow before and after PCSK-9 inhibition and to evaluate whether there is a correlation between 18F-FDG PET activity in arterial wall and hematopoietic organs (i.e. bone marrow) - circulating immune cell phenotype including but not limited to monocytes. - epigenetic changes before and after treatment	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)