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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carotid Atherosclerosis

Intervention: Atorvastatin/niacin extended-release (Drug); Atorvastatin (Drug); Simvastatin (Drug); Simvastatin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

Plaque Instability Protein Composite Score

Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: April 21, 2015

Page last updated: August 23, 2015

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