NCT01043380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

4.2 years

First QC Date

January 5, 2010

Last Update Submit

March 30, 2015

Conditions

HypercholesterolemiaCoronary Artery Disease

Keywords

Heart DiseasesHyperlipidemiaAtorvastatinEzetimibeCardiovascular DiseasesHypercholesterolemiaCoronary Artery DiseaseDyslipidemiasIntravascular Ultrasound

Outcome Measures

Primary Outcomes (1)

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

    before randomization & 9-12 months after randomization

Secondary Outcomes (11)

  • 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)

    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

  • +6 more secondary outcomes

Study Arms (2)

LZ group

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

L group

ACTIVE COMPARATOR
Drug: Lipitor (Atorvastatin) monotherapy

Interventions

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.

LZ group
Lipitor (Atorvastatin) monotherapyDRUG

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.

L group

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kumamoto University

Kumamoto, 8608556, Japan

Location

Related Publications (3)

  • 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.

    PMID: 29925472DERIVED

  • 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.

    PMID: 27318866DERIVED

  • 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.

    PMID: 26227186DERIVED

MeSH Terms

Conditions

HypercholesterolemiaCoronary Artery DiseaseHeart DiseasesHyperlipidemiasCardiovascular DiseasesDyslipidemias

Interventions

Combined Modality TherapyAtorvastatinEzetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsAzetidinesAzetines

Study Officials

  • Hisao Ogawa, MD, PhD

    Kumamoto University, Graduate School of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2014

Study Completion

September 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

JP(1)