search
Back to results

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

Primary Purpose

Carotid Atherosclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atorvastatin/niacin extended-release
Atorvastatin
Simvastatin
Simvastatin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Atherosclerosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 human immunodeficiency virus (HIV) or Hepatitis B or C
  • Patient is taking warfarin or other anticoagulants
  • Patient is taking hormone replacement therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Statin 80 mg + Niacin extended-release (ER)

    Statin 10 mg

    Arm Description

    Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.

    Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.

    Outcomes

    Primary Outcome Measures

    Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis
    Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation ("Hot" biomarkers) & 25 biomarkers associated with stability ("Cold" biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 "cold" genes, and subtracting the average Ct for the 60 "hot" genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed).
    Plaque Instability Protein Composite Score
    Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.
    Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay
    Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol - Free Cholesterol.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 8, 2008
    Last Updated
    September 28, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00804843
    Brief Title
    Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
    Acronym
    MCAT
    Official Title
    A Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Atherosclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Statin 80 mg + Niacin extended-release (ER)
    Arm Type
    Experimental
    Arm Description
    Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
    Arm Title
    Statin 10 mg
    Arm Type
    Active Comparator
    Arm Description
    Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin/niacin extended-release
    Other Intervention Name(s)
    Lipitor, Niaspan
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Other Intervention Name(s)
    Lipitor
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Other Intervention Name(s)
    Zocor
    Intervention Description
    (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.
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Other Intervention Name(s)
    Zocor
    Intervention Description
    (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.
    Primary Outcome Measure Information:
    Title
    Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis
    Description
    Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation ("Hot" biomarkers) & 25 biomarkers associated with stability ("Cold" biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 "cold" genes, and subtracting the average Ct for the 60 "hot" genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed).
    Time Frame
    At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
    Title
    Plaque Instability Protein Composite Score
    Description
    Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.
    Time Frame
    At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
    Title
    Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay
    Description
    Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol - Free Cholesterol.
    Time Frame
    At time of carotid endarterectomy (after 4 to 12 weeks of dosing)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 human immunodeficiency virus (HIV) or Hepatitis B or C Patient is taking warfarin or other anticoagulants Patient is taking hormone replacement therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs