Vascular Inflammation and Cholesterol Lowering Therapy

October 12, 2020 updated by: Rasmus S. Ripa, Rigshospitalet, Denmark
This study aim to detect change in vascular inflammation following intense lipid lowering therapy

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • treatment with PCSK-9 inhibitors

Exclusion Criteria:

  • Infection Pregnancy Severe claustrophobia Weight >140 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipid lowering
Drug: Evolocumab or Alirocumab
All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vascular inflammation
Time Frame: 12 weeks
Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Rasmus S Ripa, MD, DMSc, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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