Who is sponsoring MCAT?

MCAT is sponsored by Merck Sharp & Dohme LLC.

What condition does MCAT study?

MCAT studies Carotid Atherosclerosis.

What drugs are being tested in MCAT?

Interventions: Atorvastatin/niacin extended-release, Atorvastatin, Simvastatin, Simvastatin.

Last reviewed 2015-09-28 · How we verify

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) (MCAT)

NCT00804843 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	100
Start date	2009-04
Completion	2010-10

Conditions

Carotid Atherosclerosis

Interventions

Atorvastatin/niacin extended-release
Atorvastatin
Simvastatin
Simvastatin

Primary outcomes

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)
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 — At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
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 — At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol - Free Cholesterol.