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WithdrawnNCT02941016Updated Oct 14, 2020

Vascular Inflammation and Cholesterol Lowering Therapy

A Phase 4 interventional study of Evolocumab or Alirocumab in Lipid Lowering, Vascular Inflammation, sponsored by Rigshospitalet, Denmark. Withdrawn at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Other

Why this study was withdrawn
Logistic reasons
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study aim to detect change in vascular inflammation following intense lipid lowering therapy

02

Conditions studied

  • Lipid Lowering, Vascular Inflammation

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

Browse Inflammation studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • treatment with PCSK-9 inhibitors

Exclusion criteria

Exclusion Criteria:

  • Infection Pregnancy Severe claustrophobia Weight >140 kg
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Lipid lowering

    Drug: Evolocumab or Alirocumab

Interventions

  • DrugEvolocumab or Alirocumab

    All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol

06

What researchers measure

Primary outcomes

  1. Change in vascular inflammation

    Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy

    Time frame: 12 weeks

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02941016
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Rasmus S. Ripa (Staff Physician, Rigshospitalet, Denmark) — Principal investigator
First posted
Oct 21, 2016
Start date
Oct 2016
Primary completion
Oct 2020 (estimated)
Completion
Oct 1, 2020
Last update
Oct 14, 2020

Study contacts

Rasmus S Ripa, MD, DMSc
principal investigator · Rigshospitalet, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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