Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vascular Inflammation and Cholesterol Lowering Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02941016
Recruitment Status : Withdrawn (Logistic reasons)
First Posted : October 21, 2016
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rasmus S. Ripa, Rigshospitalet, Denmark

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aim to detect change in vascular inflammation following intense lipid lowering therapy

Condition or disease Intervention/treatment Phase
Lipid Lowering, Vascular Inflammation Drug: Evolocumab or Alirocumab Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vascular Inflammation and Cholesterol Lowering Therapy
Study Start Date : October 2016
Estimated Primary Completion Date : October 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • treatment with PCSK-9 inhibitors

Exclusion Criteria:

  • Infection Pregnancy Severe claustrophobia Weight >140 kg
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941016


Locations
Layout table for location information
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Rasmus S Ripa, MD, DMSc Rigshospitalet, Denmark
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rasmus S. Ripa, Staff Physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02941016    
Other Study ID Numbers: 0002
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes
Evolocumab
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents