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
About this trial
This is an interventional treatment trial for Carotid Atherosclerosis
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
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
NCT ID
NCT00804843
First Posted
December 8, 2008
Last Updated
September 28, 2015
Sponsor
Merck Sharp & Dohme LLC
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)
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