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The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LZ group | Experimental |
| |
| L group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] | Drug | Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion | before randomization & 9-12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume | before randomization & 9-12 months after randomization | |
| Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisao Ogawa, MD, PhD | Kumamoto University, Graduate School of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kumamoto University | Kumamoto | 8608556 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29925472 | Derived | Fujisue K, Nagamatsu S, Shimomura H, Yamashita T, Nakao K, Nakamura S, Ishihara M, Matsui K, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Sakamoto K, Izumiya Y, Kaikita K, Hokimoto S, Ogawa H, Tsujita K. Impact of statin-ezetimibe combination on coronary atheroma plaque in patients with and without chronic kidney disease - Sub-analysis of PRECISE-IVUS trial. Int J Cardiol. 2018 Oct 1;268:23-26. doi: 10.1016/j.ijcard.2018.04.051. Epub 2018 Jun 18. | |
| 27318866 |
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| Lipitor (Atorvastatin) monotherapy | Drug | The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl. |
|
| before randomization & 9-12 months after randomization |
| Percentage changes from baseline to follow-up in serum lipids | before randomization & 9-12 months after randomization |
| Correlation between regression of coronary plaque and serum lipids profiles | before randomization & 9-12 months after randomization |
| Changes in hs-CRP from baseline to follow-up | before randomization & 9-12 months after randomization |
| Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP) | before randomization & 9-12 months after randomization |
| Change and percentage change from baseline to follow-up in the PV of the PCI target lesion | before randomization & 9-12 months after randomization |
| Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion | before randomization & 9-12 months after randomization |
| MACE (cardiac death, non-fatal Q wave and/or non-Q wave myocardial infarction, target vessel revascularization [percutaneous coronary intervention or coronary artery bypass grafting]) | before randomization & 9-12 months after randomization |
| All-cause death | before randomization & 9-12 months after randomization |
| Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis) | before randomization & 9-12 months after randomization |
| Derived |
| Tsujita K, Yamanaga K, Komura N, Sakamoto K, Sugiyama S, Sumida H, Shimomura H, Yamashita T, Oka H, Nakao K, Nakamura S, Ishihara M, Matsui K, Sakaino N, Nakamura N, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Kaikita K, Hokimoto S, Ogawa H; PRECISE-IVUS Investigators. Lipid profile associated with coronary plaque regression in patients with acute coronary syndrome: Subanalysis of PRECISE-IVUS trial. Atherosclerosis. 2016 Aug;251:367-372. doi: 10.1016/j.atherosclerosis.2016.05.025. Epub 2016 May 20. |
| 26227186 | Derived | Tsujita K, Sugiyama S, Sumida H, Shimomura H, Yamashita T, Yamanaga K, Komura N, Sakamoto K, Oka H, Nakao K, Nakamura S, Ishihara M, Matsui K, Sakaino N, Nakamura N, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Kaikita K, Hokimoto S, Ogawa H; PRECISE-IVUS Investigators. Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention: The Multicenter Randomized Controlled PRECISE-IVUS Trial. J Am Coll Cardiol. 2015 Aug 4;66(5):495-507. doi: 10.1016/j.jacc.2015.05.065. |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| D006949 | Hyperlipidemias |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D000069059 | Atorvastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001384 | Azetidines |
| D001385 | Azetines |
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