Effects of Lomitapide on Carotid and Aortic Atherosclerosis

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aegerion Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Adult patients (age ≥18 years) who are enrolled in LOWER

Exclusion Criteria:

• Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy

• Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body)

• Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment

• Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans

• Patients with an implanted insulin pump

• Patients with metal shrapnel or bullet wounds

• Patients with a body mass index (BMI) > 40 kg/m2 (since it may be difficult to position comfortably with the MRI scanner)

• Patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment MRI scan has been done to rule out metal fragments in the eye)