Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED) (MCAT)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00804843
First received: December 8, 2008
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
| Condition | Intervention | Phase |
|---|---|---|
|
Carotid Atherosclerosis |
Drug: Atorvastatin/niacin extended-release Drug: Atorvastatin Drug: Simvastatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis [ Time Frame: At time of carotid endarterectomy (after 4 to 12 weeks of dosing) ] [ Designated as safety issue: No ]Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation ("Hot" biomarkers) & 25 biomarkers associated with stability ("Cold" biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 "cold" genes, and subtracting the average Ct for the 60 "hot" genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed).
- Plaque Instability Protein Composite Score [ Time Frame: At time of carotid endarterectomy (after 4 to 12 weeks of dosing) ] [ Designated as safety issue: No ]Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.
- Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay [ Time Frame: At time of carotid endarterectomy (after 4 to 12 weeks of dosing) ] [ Designated as safety issue: No ]Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol - Free Cholesterol.
| Enrollment: | 100 |
| Study Start Date: | April 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Statin 80 mg + Niacin extended-release (ER)
Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
|
Drug: Atorvastatin/niacin extended-release
80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Other Name: Lipitor, Niaspan
Drug: Simvastatin
(Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Other Name: Zocor
|
|
Active Comparator: Statin 10 mg
Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
|
Drug: Atorvastatin
10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Other Name: Lipitor
Drug: Simvastatin
(Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Other Name: Zocor
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00804843 History of Changes |
| Other Study ID Numbers: | MK-0000-111, 2008_598 |
| Study First Received: | December 8, 2008 |
| Results First Received: | December 21, 2011 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Atherosclerosis Carotid Artery Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Niacin Simvastatin Atorvastatin Nicotinic Acids Niacinamide |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
ClinicalTrials.gov processed this record on May 23, 2013