Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED) (MCAT)
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| ClinicalTrials.gov Identifier: NCT00804843 |
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Recruitment Status :
Completed
First Posted : December 9, 2008
Results First Posted : April 19, 2012
Last Update Posted : September 30, 2015
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Brief Summary:
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carotid Atherosclerosis | Drug: Atorvastatin/niacin extended-release Drug: Atorvastatin Drug: Simvastatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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) |
| Study Start Date : | April 2009 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | October 2010 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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Active Comparator: Statin 10 mg
Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
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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 |
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) ]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) ]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) ]Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol - Free Cholesterol.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804843
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT00804843 |
| Other Study ID Numbers: |
0000-111 2008_598 ( Other Identifier: Merck Study Number ) |
| First Posted: | December 9, 2008 Key Record Dates |
| Results First Posted: | April 19, 2012 |
| Last Update Posted: | September 30, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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Carotid Artery Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Niacin Atorvastatin Simvastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs |