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This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | |||
| Pravastatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy parameter is the percent change in total plaque volume for all slices of anatomically comparable segments of the target coronary artery from baseline to month 18. | ||
| The primary efficacy parameter for brachial artery vasoactivity is the nominal change (month 3 - baseline) in the percent arterial diameter change. |
| Measure | Description | Time Frame |
|---|---|---|
| The nominal change (month 18 - baseline) in total plaque volume as measured by the sum of plaque areas for all slices of anatomically comparable segments of the target coronary artery. | ||
| Changes in brachial artery vasoactivity will be correlated with changes in total cholesterol, LDL-C, triglyceride and apolipoprotein B levels following 3 months of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Los Angeles |
| California |
| 90048 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90095 | United States |
| Pfizer Investigational Site | San Diego | California | 92103-8411 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80262 | United States |
| Pfizer Investigational Site | BLUE Island | Florida | 60406 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32610 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30309 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60637 | United States |
| Pfizer Investigational Site | Shawnee Mission | Kansas | 66204 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40202 | United States |
| Pfizer Investigational Site | Auburn | Maine | 04210 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02111 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49001 | United States |
| Pfizer Investigational Site | Royal Oak | Michigan | 48073 | United States |
| Pfizer Investigational Site | Saint Clair | Michigan | 48080 | United States |
| Pfizer Investigational Site | Rochester | Minnesota | 55905 | United States |
| Pfizer Investigational Site | Albany | New York | 12208 | United States |
| Pfizer Investigational Site | New York | New York | 10029 | United States |
| Pfizer Investigational Site | Williamsville | New York | 14221 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7594 | United States |
| Pfizer Investigational Site | Greensboro | North Carolina | 27403 | United States |
| Pfizer Investigational Site | Greenville | North Carolina | 27858-4354 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44195-5066 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43210 | United States |
| Pfizer Investigational Site | Elryia | Ohio | 44035 | United States |
| Pfizer Investigational Site | Toledo | Ohio | 43614 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | United States |
| Pfizer Investigational Site | Allentown | Pennsylvania | 18106 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Pfizer Investigational Site | Providence | Rhode Island | 02903 | United States |
| Pfizer Investigational Site | Providence | Rhode Island | 02906 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78284-6205 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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