Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Condition: Coronary Artery Disease; Carotid Artery Diseases; Atherosclerosis
MeSH terms: Carotid Artery Diseases; Coronary Artery Disease; Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls
      of arteries. This study will examine the effectiveness of a combination of
      cholesterol-lowering medications at decreasing the fat content of atherosclerotic deposits in
      people who have coronary artery disease or carotid artery disease.
    

Detailed description: 
      Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances
      build up along the inner walls of arteries; these deposits are known as plaque. People with
      atherosclerosis are at risk of developing coronary artery disease, in which plaque build-up
      occurs in the arteries that supply blood to the heart, and carotid artery disease, in which
      plaque build-up occurs in the arteries that deliver blood through the neck to the brain.
      These conditions can lead to blood clots, heart attack, and stroke. Research has shown that
      people who have more fat content in atherosclerotic plaque may have a higher risk of
      experiencing a heart attack or stroke. Treatments for atherosclerosis include lifestyle
      changes, medicines, and medical procedures or surgery. There are several medications that can
      aid people in controlling their cholesterol levels, including atorvastatin, a medication that
      inhibits the production of cholesterol; niacin, a B-complex vitamin that can reduce
      cholesterol levels in combination with dietary changes; and colesevelam, a medication that
      inhibits fat absorption. Using magnetic resonance imaging (MRI), this study will evaluate
      whether these medications, alone or in combination, can decrease the fat content of
      atherosclerotic plaques within the carotid arteries of people with coronary artery disease
      and carotid artery disease.

      This study will enroll people with coronary artery disease or carotid artery disease.
      Participants will be randomly assigned to one of the following 40-month treatment groups:

        -  Group 1 participants will receive atorvastatin, placebo niacin, and placebo colesevelam
           each day.

        -  Group 2 participants will receive atorvastatin, niacin, and placebo colesevelam each
           day.

        -  Group 3 participants will receive atorvastatin, niacin, and colesevelam each day.

      At a baseline study visit, participants will undergo a blood collection and will receive
      dietary counseling that will focus on lowering cholesterol levels. They will also undergo an
      MRI scan of their carotid arteries. For the next 4 months, participants will attend monthly
      study visits for repeat blood collection and dietary counseling; for the subsequent 36
      months, participants will attend study visits every other month. Repeat carotid artery MRI
      scans will occur at Months 12, 24, and 36. At three different times during the study,
      researchers will ask participants to record their food consumption for 3 consecutive days.
    

Intervention name(s): Atorvastatin; Niacin; Colesevelam; Placebo Niacin; Placebo Colesevelam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 to 80 mg of atorvastatin each day; 2000 mg of niacin each day; 3.8 g of colesevelam each day; Placebo niacin each day; Placebo colesevelam each day
Other intervention name(s): Lipitor; Niaspan; Slo-niacin; WelChol
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Atorvastatin; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Magnetic Resonance Imaging; Atherosclerotic Plaque; Lipid Lowering Therapy