Phase 2
Completed N=100
Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
Source: ClinicalTrials.gov NCT00804843 ↗Enrolled (actual)
100
Serious AEs
16.0%
Results posted
Apr 2012
Primary outcomePrimary: 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
Summary
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
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 |
— | — |
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
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. Informational only — not medical advice.