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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Carotid Atherosclerosis

Treatments: Drug: Atorvastatin; Drug: Atorvastatin/niacin extended-release; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804843

0000-111

2008_598 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Statin 80 mg + Niacin extended-release (ER)

Experimental group

Description:

Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.

Treatment:

Drug: Atorvastatin/niacin extended-release

Drug: Simvastatin

Drug: Simvastatin

Statin 10 mg

Active Comparator group

Description:

Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.

Treatment:

Drug: Simvastatin

Drug: Atorvastatin

Drug: Simvastatin