| Primary | Absolute Change in Relative FMD (%) | The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24. | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | % FMD | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.60(-1.58 to 2.28)
- OG0010.50(-0.97 to 2.98)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Sign test | Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry. | 0.28 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | | | | Sign test | |
|
| Secondary | Change in Cholesterol | Absolute change in total cholesterol from week 0 to week 24. | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan and had lipid panels at weeks 0 and 24. | Posted | | Median | Inter-Quartile Range | mg/dL | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in Triglycerides | Change in Triglycerides (mg/dL) from week 0 to week 24. | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | mg/dL | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Men: Change in HDL Cholesterol | Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24. | Men in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | mg/dL | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Women: Change in HDL Cholesterol | Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24. | Women in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | mg/dL | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in HDL Particles | Change in total HDL particles from week 0 to week 24 | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | nmol/L | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in Non-HDL Cholesterol | Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24. | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | mg/dL | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in LDL Cholesterol | Change in LDL cholesterol (mg/dL) from week 0 to week 24. | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | mg/dL | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in Small LDL Particles | Change in Small LDL particles from week 0 to week 24. | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | nmol/L | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in Large HDL Particles | Change in Large HDL Particles from week 0 to week 24 | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | nmol/L | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in HOMA-IR | Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | HOMA IR Score | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in IL-6 | Change in IL-6 from week 0 to week 24 | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | pg/ml | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in C-reactive Protein (CRP) | Change in C-reactive protein from week 0 to week 24. | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | ug/ml | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |
| Secondary | Change in D-Dimer | Change in D-Dimer from week 0 to week 24 | This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan. | Posted | | Median | Inter-Quartile Range | ug/ml | | 0 and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Extended-release Niacin With Aspirin | Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24. | | OG001 | Arm B: Fenofibrate | Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks. |
| |