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The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + background low to moderate dose statin | Active Comparator | Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks |
|
| BMS-582949 + Background low to moderate dose statin | Experimental | BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks |
|
| Atorvastatin | Active Comparator | Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other |
| ||
| BMS-582949 |
| Measure | Description | Time Frame |
|---|---|---|
| FDG-PET signal of the carotid and/or ascending aorta | at 4 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory and thrombotic biomarkers | will be measured throughout the 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Clinical Research, Llc | Chiefland | Florida | 32626 | United States | ||
| Jacksonville Center For Clinical Research - Univ Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25913664 | Derived | Emami H, Vucic E, Subramanian S, Abdelbaky A, Fayad ZA, Du S, Roth E, Ballantyne CM, Mohler ER, Farkouh ME, Kim J, Farmer M, Li L, Ehlgen A, Langenickel TH, Velasquez L, Hayes W, Tawakol A. The effect of BMS-582949, a P38 mitogen-activated protein kinase (P38 MAPK) inhibitor on arterial inflammation: a multicenter FDG-PET trial. Atherosclerosis. 2015 Jun;240(2):490-6. doi: 10.1016/j.atherosclerosis.2015.03.039. Epub 2015 Mar 28. |
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| Drug |
|
| Atorvastatin | Drug |
|
| Statin | Drug |
|
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Florida Cardiovascular Institute | Tampa | Florida | 33609 | United States |
| Phillip D. Toth, Md | Indianapolis | Indiana | 46260 | United States |
| L-Marc Research Center | Louisville | Kentucky | 40213 | United States |
| Commonwealth Biomedical Research, Llc | Madisonville | Kentucky | 42431 | United States |
| Mgh Cardiac Mr Pet Ct Program | Boston | Massachusetts | 02114 | United States |
| Troy Internal Medince Pc/Research | Troy | Michigan | 48098 | United States |
| Radiant Research, Inc. | Edina | Minnesota | 55435 | United States |
| Mount Sinai School Of Medicine Imaging Science Laboratories | New York | New York | 10029 | United States |
| The Lipid Center | Statesville | North Carolina | 28677 | United States |
| Metabolic And Atherosclerosis Research Center | Cincinnati | Ohio | 45212 | United States |
| Sterling Research Group | Cincinnati | Ohio | 45219 | United States |
| Hospital Of The University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Radiant Research, Inc. | Dallas | Texas | 75231 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Mcallen Heart Clinic | McAllen | Texas | 78503 | United States |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C552704 | 4-(5-(cyclopropylcarbamoyl)-2-methylphenylamino)-5-methyl-N-propylpyrrolo(1,2-f)(1,2,4)triazine-6-carboxamide |
| D000069059 | Atorvastatin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
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