Assessment Of Vascular Health After Niacin Therapy (AVANT)

University of Pennsylvania

Status: Completed

Conditions: Coronary Artery Disease; Carotid Artery Disease; Peripheral Artery Disease

Treatments: Drug: Placebo; Drug: Niacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02003638

812962

Details and patient eligibility

About

This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and favorably affect circulating levels of endothelial progenitor cells and microparticles in people with atherosclerotic disease on chronic statin therapy.

Enrollment: 9 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men age 55 years and above with coronary artery disease or women age 65 years and above with coronary artery disease OR Men age 45 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease or women age 55 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease.
• Subjects must be on statin monotherapy, defined as a stable statin dose for at least 12 weeks, with no anticipated need for further titration during the study period

Exclusion criteria

• Anxiety or claustrophobia prohibiting imaging
• History of allergy to intravenous contrast, iodine, or shellfish
• Renal insufficiency
• History of allergy or severe intolerance to niacin
• History of diabetes mellitus or elevated fasting glucose
• Moderate to severe gout
• Peptic ulcer disease
• Acute coronary syndrome, transient ischemic attack or cerebrovascular accident, or acute limb ischemia in the preceding 12 months
• Heart failure or unstable angina pectoris
• Use of daily non-statin lipid-altering therapy prior to the initiation of study medication

Trial design

9 participants in 2 patient groups, including a placebo group

Niacin

Experimental group

Description:

Niacin titrated up to 6 grams taken orally every day for 12 weeks

Treatment:

Drug: Niacin

Placebo

Placebo Comparator group

Description:

Placebo taken orally every day for 12 weeks

Treatment:

Drug: Placebo