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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. Identifier: NCT02941016
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Rasmus S. Ripa, Rigshospitalet, Denmark

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

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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

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

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

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.

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

Inclusion Criteria:

  • treatment with PCSK-9 inhibitors

Exclusion Criteria:

  • Infection Pregnancy Severe claustrophobia Weight >140 kg

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 identifier (NCT number): NCT02941016

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Contact: Rasmus S Ripa, MD, DMSc 35453545

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Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lia Bang, MD, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Rasmus S Ripa, MD, DMSc Rigshospitalet, Denmark

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Responsible Party: Rasmus S. Ripa, Staff Physician, Rigshospitalet, Denmark 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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Pathologic Processes
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents