Phase 2 N=100 Randomized Double-blind Treatment

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

Carotid Atherosclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00804843 ↗

Enrolled (actual)

100

Serious AEs

16.0%

Results posted

Apr 2012

Primary outcome: Primary: Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis — 1.36; 0.82 Cycle threshold (Ct) — p=0.811

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Atorvastatin/niacin extended-release (Drug); Atorvastatin (Drug); Simvastatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis	1.36; 0.82	0.811
PRIMARY Plaque Instability Protein Composite Score	-7.19; -10.48	0.898
PRIMARY Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay	—	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00804843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.