Merck Carotid Atherosclerosis Trial (MCAT)


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 8, 2008)		Comparison of plaque stability biomarkers and cholesterol levels following treatment [ Time Frame: 4 to 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00804843 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJEMerck Carotid Atherosclerosis Trial
Official Title  ICMJEA Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA)
Brief Summary

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

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJECarotid Atherosclerosis
Intervention  ICMJE
  • Drug: Atorvastatin/niacin extended-release
    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.
    Other Name: Lipitor, Niaspan
  • Drug: Atorvastatin
    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.
    Other Name: Lipitor
  • Drug: Simvastatin
    (Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin 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.
    Other Name: Zocor
  • Drug: Simvastatin
    (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.
    Other Name: Zocor
Study Arms / Comparison Groups
  • A: Experimental
    statin/niacin extended-release
    Interventions:
    • Drug: Atorvastatin/niacin extended-release
    • Drug: Simvastatin
  • B: Active Comparator
    statin
    Interventions:
    • Drug: Atorvastatin
    • Drug: Simvastatin

Recruitment Information

Estimated Enrollment  ICMJE100
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is diagnosed with carotid stenosis AND is scheduled to undergo carotid endarterectomy
  • Female patients of reproductive potential must abstain from sex or use an acceptable method of birth control through out the study

Exclusion Criteria:

  • Patient must undergo CEA less than 4 weeks after entering study
  • Patient has recent history of acute coronary syndrome
  • Patient has has coronary artery bypass graft surgery within 30 days of study start
  • Patient has thyroid disease that has not been treated for more than 6 weeks
  • Patient has donated blood within 8 weeks of study start
  • Patient has poorly controlled diabetes mellitis
  • Patient has HIV or Hepatitis B or C
  • Patient is taking warfarin or other anticoagulants
  • Patient is taking hormone replacement therapy
GenderBoth
Ages18 Years to 90 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Czech Republic,   Italy,   Russian Federation,   Spain

Administrative Information

NCT ID  ICMJENCT00804843
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2008_598, 111
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck