carotid atherosclerosis MedDRA version: 9.1 Level: LLT Classification code 10003601 Term: Atherosclerosis
Conditions
Interventions
Trade Name: LIPITOR
Pharmaceutical Form: Tablet
Other descriptive name: atorvastatin
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is: a) Diagnosed with a symptomatic or an asymptomatic carotid stenosis b) AND scheduled to undergo a carotid endarterectomy with either symptomatic or asymptomatic carotid stenosis: 2) Patient has critical carotid artery stenosis requiring non-emergent carotid endarterectomy. The duration of time between randomization and carotid endarterectomy is anticipated to be at least 4 weeks. After randomization, 4 to 12 weeks of drug treatment is permitted for patients to remain in the study in order to provide flexibility given that the timing of CEA may change after enrollment. Patients that have not completed 4 to 12 weeks of treatment will be discontinued from the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient requires emergent CEA to be performed in less than 4 weeks. 2). Patient has taken statin therapy with potency greater than the equivalent of atorvastatin 10 mg per day in past 3 months. Simvastatin (Zocor™) >20 mg/day Atorvastatin (Lipitor™) >10 mg/day Lovastatin (Mevacor™; Altocor™) >40 mg/day Fluvastatin (Lescol™) >40 mg/day Pravastatin (Pravachol™) >40 mg/day Rosuvastatin (Crestor™) >5 mg/day 3) Patient has prior Niacin use =500 mg/day in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoints are the composite Hot/Cold RNA biomarker panel; Plaque Instability Protein composite; and cholesterol content; and these endpoints will be compared between the groups via analysis of variance.; Main Objective: To determine whether 4 to 12 weeks of treatment with statin 80 mg/day + niacin ER 2 g/day compared to low dose statin 10 mg/day will result in a difference in the following endpoints: (1) Composite score of “plaque inflammation/stability” gene expression as assayed by RNA Taqman analysis (referred to as “Hot/Cold” RNA biomarker panel); (2) Plaque Instability Protein Composite Score; (3) Cholesterol content. ; Secondary Objective: 1) To determine whether 4 to 12 weeks of treatment for symptomatic patients with statin 80 mg/day + niacin ER 2 g/day will result in a significant difference in RNA/protein/histological/lipid plaque stability biomarkers compared to symptomatic patients who receive treatment of statin 10 mg/day. The same comparison will be done on the strata of asymptomatic patients. 2) To determine whether 4 to 12 weeks of treatment with statin 80 mg/day + niacin ER 2 g/day compared to patients who receive statin 10 mg/day will result in a significant difference in secondary endpoints that include: plaque histology/immunohistochemistry (IHC), other protein analytes, and microarray RNA expression profiling. This includes new biomarkers identified in carotid plaque and blood from analysis of endpoints, and includes analysis of endpoints using specific regions of the carotid plaque. Please see protocol details section for further clarification of secondary endpoints. | — |
Countries
Czech Republic, Italy
Outcome results
None listed