Clinical trial NCT01043380: Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
Official title: Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Coronary Artery Disease
Keywords: Heart Diseases
Hyperlipidemia
Atorvastatin
Ezetimibe
Cardiovascular Diseases
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Intravascular Ultrasound
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 245
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent,
* 30 to 85 years old,
* Plan to undergo PCI and LDL-C \>= 100 mg/dL

Exclusion Criteria:

* Familial hypercholesterolemia
* 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

Primary outcomes:
measure: Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion
timeFrame: before randomization & 9-12 months after randomization
Secondary outcomes:
measure: Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume
timeFrame: before randomization & 9-12 months after randomization
measure: Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)
timeFrame: before randomization & 9-12 months after randomization
measure: Percentage changes from baseline to follow-up in serum lipids
timeFrame: before randomization & 9-12 months after randomization
measure: Correlation between regression of coronary plaque and serum lipids profiles
timeFrame: before randomization & 9-12 months after randomization
measure: Changes in hs-CRP from baseline to follow-up
timeFrame: before randomization & 9-12 months after randomization
measure: Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)
timeFrame: before randomization & 9-12 months after randomization
measure: Change and percentage change from baseline to follow-up in the PV of the PCI target lesion
timeFrame: before randomization & 9-12 months after randomization
measure: Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion
timeFrame: before randomization & 9-12 months after randomization
measure: 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])
timeFrame: before randomization & 9-12 months after randomization
measure: All-cause death
timeFrame: before randomization & 9-12 months after randomization
measure: Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)
timeFrame: before randomization & 9-12 months after randomization
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Kumamoto University
Study officials:
affiliation: Kumamoto University, Graduate School of Medical Sciences
name: Hisao Ogawa, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.