Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED) "MCAT"

Completed

Phase 2 Results

Trial Description

This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers

Conditions

Interventions

  • Atorvastatin (LipitorĀ®)Drug
    Other Names: Lipitor
    Intervention Desc: 10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
    ARM 1: Kind: Experimental
    Label: B
    Description: statin
    ARM 2: Kind: Experimental
    Label: Statin 10 mg
    Description: Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
  • Simvastatin Drug
    Intervention Desc: (Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
    ARM 1: Kind: Experimental
    Label: A
    Description: statin/niacin extended-release
    ARM 2: Kind: Experimental
    Label: B
    Description: statin
    ARM 3: Kind: Experimental
    Label: Statin 80 mg + Niacin extended-release (ER)
    Description: Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
    ARM 4: Kind: Experimental
    Label: Statin 10 mg
    Description: Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
  • Niacin Extended Release (Niaspan)Drug
    Intervention Desc: organic compound used to improve blood cholesterol or lower fats (called triglycerides or lipids) in the blood.
  • Atorvastatin/niacin extended-release Drug
    Other Names: Lipitor, Niaspan
    Intervention Desc: 80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
    ARM 1: Kind: Experimental
    Label: A
    Description: statin/niacin extended-release
    ARM 2: Kind: Experimental
    Label: Statin 80 mg + Niacin extended-release (ER)
    Description: Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms after CEA. Either statin and extended release niacin or arm two statin and placebo. Treatment will be 4 to 12 weeks.

Outcomes

Type Measure Time Frame Safety Issue
Primary Comparison of plaque stability biomarkers and cholesterol levels following treatment
Primary Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis At time of carotid endarterectomy (after 4 to 12 weeks of dosing) No
Primary Plaque Instability Protein Composite Score At time of carotid endarterectomy (after 4 to 12 weeks of dosing) No
Primary Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay At time of carotid endarterectomy (after 4 to 12 weeks of dosing) No

Sponsors