Effect of Evolocumab on Coronary Atherosclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

March 19, 2019

Primary Completion Date

January 28, 2023

Study Completion Date

May 30, 2023

Conditions
Cardiovascular DiseaseHyperlipidemia
Interventions
DRUG

Evolocumab

"Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.~Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector."

DIAGNOSTIC_TEST

18F-NaF PET

18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.

DIAGNOSTIC_TEST

CCTA

CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.

DRUG

Omnipaque

contrast agent for CCTA

DRUG

Metoprolol

beta blocker to optimize heart rate during CCTA

DRUG

Nitroglycerin

premedication for CCTA

Trial Locations (1)

90048

Cedars-Sinai Medical Center, Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Cedars-Sinai Medical Center

OTHER