Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
NCT ID: NCT01043380
Last Updated: 2015-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
245 participants
INTERVENTIONAL
2010-01-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LZ group
Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
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.
L group
Lipitor (Atorvastatin) monotherapy
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.
Interventions
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Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
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.
Lipitor (Atorvastatin) monotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 30 to 85 years old,
* Plan to undergo PCI and LDL-C \>= 100 mg/dL
Exclusion Criteria
* Being treated with Zetia (Ezetimibe)
* Being treated with Fibrates
* Renal insufficiency (serum creatinine \>= 2.0 mg/dl)
* Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase \>= 3-folds of standard value in each institute)
* Undergoing hemodialysis or peritoneal dialysis
* Allergic to Lipitor and/or Zetia
* Severe underlying disease
* Lack of decision-making capacity
* Recognized as inadequate by attending doctor
30 Years
85 Years
ALL
No
Sponsors
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Kumamoto University
OTHER
Responsible Party
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Hisao Ogawa
Professor
Principal Investigators
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Hisao Ogawa, MD, PhD
Role: STUDY_CHAIR
Kumamoto University, Graduate School of Medical Sciences
Locations
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Kumamoto University
Kumamoto, , Japan
Countries
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References
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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.
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.
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.
Other Identifiers
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UMIN000002959
Identifier Type: -
Identifier Source: org_study_id
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