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) - Carotid Plaque POC Study

Phase 1

• Conditions: carotid atherosclerosis; MedDRA version: 9.1 Level: LLT Classification code 10003601 Term: Atherosclerosis

• Registration Number: EUCTR2008-008006-46-CZ
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-03
• Study Completion: 2010-10-22
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified