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

Carotid Atherosclerosis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804843
• Other study ID #: 0000-111
• Secondary ID: 2008_598
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2008
• Last updated: September 28, 2015
• Start date: April 2009
• Est. completion date: October 2010

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
Primary	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.	At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
Primary	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.	At time of carotid endarterectomy (after 4 to 12 weeks of dosing)