Assessment Of Vascular Health After Niacin Therapy (AVANT)

NCT ID: NCT02003638

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

Conditions

Coronary Artery Disease; Carotid Artery Disease; Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Niacin

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

Group Type: EXPERIMENTAL

Niacin

Intervention Type: DRUG

Niacin titrated to 6000 mg daily

Placebo

Placebo taken orally every day for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo provided in the same pill quantity as niacin arm

Interventions

Niacin

Niacin titrated to 6000 mg daily

Intervention Type: DRUG

Placebo

Placebo provided in the same pill quantity as niacin arm

Intervention Type: DRUG

Other Intervention Names

Niaspan; Niacor; Sugar pill

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Emil deGoma

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emil deGoma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

812962

Identifier Type: -

Identifier Source: org_study_id