Back to resultsVascular Inflammation and Cholesterol Lowering Therapy
Primary Purpose
Lipid Lowering, Vascular Inflammation
Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Evolocumab or Alirocumab
Sponsored by
About this trial
This is an interventional other trial for Lipid Lowering, Vascular Inflammation
Eligibility Criteria
Inclusion Criteria:
- treatment with PCSK-9 inhibitors
Exclusion Criteria:
- Infection Pregnancy Severe claustrophobia Weight >140 kg
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lipid lowering
Arm Description
Outcomes
Primary Outcome Measures
Change in vascular inflammation
Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT02941016
First Posted
October 18, 2016
Last Updated
October 12, 2020
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02941016
Brief Title
Vascular Inflammation and Cholesterol Lowering Therapy
Official Title
Vascular Inflammation and Cholesterol Lowering Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Logistic reasons
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
This study aim to detect change in vascular inflammation following intense lipid lowering therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Lowering, Vascular Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lipid lowering
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Evolocumab or Alirocumab
Intervention Description
All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol
Primary Outcome Measure Information:
Title
Change in vascular inflammation
Description
Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
treatment with PCSK-9 inhibitors
Exclusion Criteria:
Infection Pregnancy Severe claustrophobia Weight >140 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmus S Ripa, MD, DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Vascular Inflammation and Cholesterol Lowering Therapy
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