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


- candidate number28323
- NTR NumberNTR6884
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-dec-2017
- Secondary IDs2016_321 METC AMC
- Public TitleArterial wall inflammation measured with 18F-FDG PET/CT in patients with statin intolerance before and after monotherapy with a PCSK-9 inhibitor
- Scientific TitleArterial wall inflammation measured with 18F-FDG PET/CT in patients with statin intolerance before and after monotherapy with a PCSK-9 inhibitor
- ACRONYMVISTA
- hypothesisTo assess arterial wall inflammation, measured with 18F-FDG PET/CT, in patients with increased CV-risk and statin intolerance due to statin-associated muscle symptoms, as well as the change in arterial wall inflammation following PCSK9 inhibition.
- Healt Condition(s) or Problem(s) studiedCardiovascular risk , Statin intolerance
- Inclusion criteriaIncreased CV-risk
Aged 50 years and older
Statin-associated muscle symptoms for at least 3 different statins
LDL-C > 100 mg/dL
- Exclusion criteriaMajor exclusion criteria:
CV-event in last 3 months
Diabetes Mellitus
Systemic auto-immune disease
Cancer
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-mei-2017
- planned closingdate1-jul-2019
- Target number of participants50
- InterventionsPlacebo or Alirocumab 150 mg s.c. once every two weeks
- Primary outcomeThe primary endpoint is the change in 18F-FDG target to background ratio (TBR) following 12 weeks of PCSK-9 inhibition
- Secondary outcomeThe 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) and circulating immune cell phenotype including but not limited to monocytes.
- TimepointsTwo weekly treatment for 12 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.M. Hoogeveen
- CONTACT for SCIENTIFIC QUERIES R.M. Hoogeveen
- Sponsor/Initiator University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Regeneron, European Unionís Horizon 2020 research and innovation programme, grant agreement No 667837
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD8-dec-2017 - 27-dec-2017


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