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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000001229 |
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This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. |
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| 2 | Active Comparator | Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| absolute changes in carotid intima-media thickness from baseline to final visit | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| relative change in carotid intima-media thickness | 12 months | |
| change in LDL-C, HDL-C, TG and RLP-C | 12 months | |
| change in hs-CRP and IL-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Matsubara, MD, PhD | Kyoto Prefectural University of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayabe City Hospital | Ayabe | Kyoto | 623-0011 | Japan | ||
| Fukuchiyama City Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37565307 | Derived | Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2. | |
| 22689416 | Derived | Ikeda K, Takahashi T, Yamada H, Matsui K, Sawada T, Nakamura T, Matsubara H; (for the PEACE Investigators). Effect of intensive statin therapy on regression of carotid intima-media thickness in patients with subclinical carotid atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study). Eur J Prev Cardiol. 2013 Dec;20(6):1069-79. doi: 10.1177/2047487312451539. Epub 2012 Jun 11. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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| Pitavastatin | Drug | Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. |
|
| 12 months |
| new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans | 12 months |
| sudden death | 12 months |
| side effects | 12 months |
| Fukuchiyama |
| Kyoto |
| 620-8505 |
| Japan |
| Saiseikai Kyoto Hospital | Kōtari | Kyoto | 617-0814 | Japan |
| Takeda Hospital | Kyoto | Kyoto | 600-8558 | Japan |
| Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| Kyoto First Red Cross Hospital | Kyoto | Kyoto | 605-0981 | Japan |
| Tanabe Central Hospital | Kyōtanabe | Kyoto | 610-0334 | Japan |
| Kumihama Hospital | Kyōtango | Kyoto | 629-3400 | Japan |
| Maizuru Medical Center | Maizuru | Kyoto | 625-8502 | Japan |
| Maizuru Kyosai Hospital | Maizuru | Kyoto | 625-8585 | Japan |
| Nantan General Hospital | Nantan | Kyoto | 629-0197 | Japan |
| Meiji University of Integrative Medicine Hospital | Nantan | Kyoto | 629-0392 | Japan |
| Gakken Toshi Hospital | Sugai | Kyoto | 619-0238 | Japan |
| Uji Hospital | Uji | Kyoto | 611-0011 | Japan |
| Kyoto Prefectural Yosanoumi Hospital | Yotsutsuji | Kyoto | 629-2261 | Japan |
| Shiga Hospital | Higashioumi | Shiga | 527-8505 | Japan |
| Omihachiman Community Medical Center | Ōmihachiman | Shiga | 523-0082 | Japan |
| Saiseikai Shigaken Hospital | Rittou | Shiga | 520-3046 | Japan |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |