Other Clinical Trial - Vascular Inflammation & Cholesterol NCT02941016

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Withdrawn

This study aim to detect change in vascular inflammation following intense lipid lowering therapy

Recruitment information / eligibility
Status	Withdrawn
Enrollment	0
Est. completion date	October 1, 2020
Est. primary completion date	October 2020
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - treatment with PCSK-9 inhibitors Exclusion Criteria: - Infection Pregnancy Severe claustrophobia Weight >140 kg

Drug:
• Evolocumab or Alirocumab
All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol

Locations
Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors *(1)*
Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Denmark,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Change in vascular inflammation	Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy	12 weeks