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CompletedNCT01043380PRECISE-IVUSUpdated Apr 1, 2015

Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound

A Phase 4 interventional study of Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] and Lipitor (Atorvastatin) monotherapy in Hypercholesterolemia and Coronary Artery Disease, sponsored by Kumamoto University. Completed at 1 site in Japan. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-04-01.

Sponsored by Kumamoto University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
245
Allocation
Randomized
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia
  • Coronary Artery Disease

Keywords

  • Heart Diseases
  • Hyperlipidemia
  • Atorvastatin
  • Ezetimibe
  • Cardiovascular Diseases
  • Hypercholesterolemia
  • Coronary Artery Disease
  • Dyslipidemias
  • Intravascular Ultrasound
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 245 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Kumamoto University is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
245 participants (actual)

Study arms

  • Experimental
    LZ group

    Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]

  • Active comparator
    L group

    Drug: Lipitor (Atorvastatin) monotherapy

Interventions

  • DrugCombination 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.

  • DrugLipitor (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.

06

What researchers measure

Primary outcomes

  1. Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion

    Time frame: before randomization & 9-12 months after randomization

Secondary outcomes

  1. Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume

    Time frame: before randomization & 9-12 months after randomization

  2. Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)

    Time frame: before randomization & 9-12 months after randomization

  3. Percentage changes from baseline to follow-up in serum lipids

    Time frame: before randomization & 9-12 months after randomization

  4. Correlation between regression of coronary plaque and serum lipids profiles

    Time frame: before randomization & 9-12 months after randomization

  5. Changes in hs-CRP from baseline to follow-up

    Time frame: before randomization & 9-12 months after randomization

  6. Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)

    Time frame: before randomization & 9-12 months after randomization

  7. Change and percentage change from baseline to follow-up in the PV of the PCI target lesion

    Time frame: before randomization & 9-12 months after randomization

  8. Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion

    Time frame: before randomization & 9-12 months after randomization

  9. 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])

    Time frame: before randomization & 9-12 months after randomization

  10. All-cause death

    Time frame: before randomization & 9-12 months after randomization

  11. Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)

    Time frame: before randomization & 9-12 months after randomization

07

Study locations

1 site
  • Kumamoto University
    Kumamoto, 8608556, Japan
08

References and documents

Publications

  • 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. PubMed 29925472 ↗
  • 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. PubMed 27318866 ↗
  • 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. PubMed 26227186 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01043380
Lead sponsor
Kumamoto University
Responsible party
Hisao Ogawa (Professor, Kumamoto University) — Principal investigator
First posted
Jan 6, 2010
Start date
Jan 2010
Primary completion
Mar 2014
Completion
Sep 2014
Last update
Apr 1, 2015

Study contacts

Hisao Ogawa, MD, PhD
study chair · Kumamoto University, Graduate School of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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