UMIN-CTR Clinical Trial

Public title

Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound

Acronym

The PRECISE-IVUS trial

Scientific Title

Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound

Scientific Title:Acronym

The PRECISE-IVUS trial

Region

Japan

Condition

patients aged 30-85 years who
were undergoing percutaneous coronary intervention (PCI, elective or emergency) with >=1 significant
stenosis >=75% and >=1 untouched nonculprit lesion of <=50% stenosis that could be imaged by intravascular ultrasound, and either LDL-C >=100 mg/dl.

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Absolute change from baseline (before randomization) to follow-up (9-12 momths after randomization) in the percentage atheroma volume (PAV)

Key secondary outcomes

- % change from baseline (before randomization) to follow-up (9-12 momths after randomization) in the plaque volume (PV)
- Change from baseline to follow-up in PV in the target lesion
- Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)
- Percentage changes from baseline to follow-up in serum lipids
- Correlation between regression of coronary plaque and serum lipids profiles
- Changes in hs-CRP from baseline to follow-up
- Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)
- Change and percentage change from baseline to follow-up in the PV of the PCI target lesion
- Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion
- MACE (cardiac death, non-fatal Q wave and/or non-Q wave myocardial infarction, target vessel revascularization [percuatneous coronary intervention or coronary artery bypass grafting])
- All-cause death
- Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)
- Change in percent atheroma volume
- Subgroup analysis based on characteristics at the time of randomization
- acute coronary syndrome and stable angina pectoris
- men and women
- diabetes and no diabetes
- age: 30-39, 40-49, 50-59, 60-69, 70-79, >=80
- smokers and nonsmokers
- approximate tertiles of lipid parameters: totalcholesterol, LDL-cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, apolipoprotein B, apolipoprotein A1
- systolic blood pressure: <140, 140-159, 160-179, >=180 mmHg
- approximate tertiles of body mass index, waist circumference, hemoglobin, plasma albumin
- use of particular drugs, including antiplatelet therapy, oral anticoagulants, angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker, beta-blocker, calcium-channel blocker, diuretic, erythropoietin

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

- 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/Control_2

- LZ group (Combination therapy with Lipitor 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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

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

Key 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

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Hisao Ogawa

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto City

TEL

096-373-5175

Email

ogawah@kumamoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenichi Tsujita

Organization

Graduate School of Medical Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto City

TEL

096-373-5175

Homepage URL

Email

tsujita@kumamoto-u.ac.jp

Institute

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Institute

Department

Personal name

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新東京病院（千葉県）、新小文字病院（福岡県）、福岡徳洲会病院（福岡県）、荒尾市民病院（熊本県）、公立玉名中央病院（熊本県）、 熊本赤十字病院（熊本県）、国立病院機構熊本医療センター（熊本県）、 熊本労災病院（熊本県）、 済生会熊本病院（熊本県）、熊本中央病院（熊本県）、八代総合病院（熊本県）、天草地域医療センター（熊本県）、人吉総合病院（熊本県）、宮崎県立延岡病院（宮崎県）、熊本地域医療センター医師会病院（熊本県）、社会保険大牟田天領病院（福岡県）、熊本市立熊本市民病院（熊本県）、水俣市立総合医療センター（熊本県）、熊本大学医学部附属病院（熊本県）

Date of disclosure of the study information

2010

Year

01

Month

06

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S0735109715026820

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2010

Year

01

Month

06

Day

Date of IRB

Anticipated trial start date

2010

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

12

Month

31

Day

Last modified on

2016

Year

01

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003599