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Completed

NCT Number: NCT00804843

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

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

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Key information

Conditions

Carotid Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin/niacin extended-release

Drug

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 names: Lipitor, Niaspan

atorvastatin

Drug

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 names: Lipitor

simvastatin

Drug

(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 names: Zocor

Primary outcomes

  1. Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis

    Time frame: 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).

  2. Plaque Instability Protein Composite Score

    Time frame: 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.

  3. Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Acronym: MCAT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2008
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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