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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02941016
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Rasmus S. Ripa, Rigshospitalet, Denmark

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Vascular Inflammation and Cholesterol Lowering Therapy
Study Start Date : October 2016
Estimated Primary Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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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


Contacts
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Contact: Rasmus S Ripa, MD, DMSc 35453545

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lia Bang, MD, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Rasmus S Ripa, MD, DMSc Rigshospitalet, Denmark
More Information
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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 21, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Evolocumab
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents