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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin Arm | Experimental | Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily |
|
| Olmesartan Arm | Experimental | Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily |
|
| Combination Arm | Experimental | Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug |
| ||
| Olmesartan |
| Measure | Description | Time Frame |
|---|---|---|
| PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries | Left main, LAD proximal to mid (from ostium to a large second diagonal branch), LCX proximal (from ostium to a large first obtuse marginal branch), RCA (from ostium to a distal bifurcation) | Over the 48weeks |
| Measure | Description | Time Frame |
|---|---|---|
| TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries | Left main, LAD proximal to mid (from ostium to a large second diagonal branch), LCX proximal (from ostium to a large first obtuse marginal branch), RCA (from ostium to a distal bifurcation) | Over the 48weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyeon-Cheol Gwon, PhD | Contact | 2-3410-3418 | 82 | hcqwon@skku.edu |
| Young Bin Song, PhD | Contact | 2-3410-3419 | 82 | yoingbin.song@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyeon-Cheol Gwon, PhD | Samsung Medical Center,Seoul,Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac and Vascular Center; Samsung Medical Center | Seoul | 135-710 | South Korea |
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|
| Combination | Drug | Rosuvastatin/Olmesartan(Combination) |
|
| Placebo of Rosuvastatin | Drug |
|
| Placebo of Olmesartan | Drug |
|
| Placebo of Rosuvastatin/Olmesartan(Combination) | Drug |
|
| LAPV (nominal change of percent low attenuation plaque volume) |
| Over the 48weeks |
| Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity | Over the 48weeks |
| Change in insulin resistance | Over the 48weeks |
| Major adverse cardiac events | Over the 48weeks |
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C437965 | olmesartan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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