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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002959
Receipt No. R000003599
Scientific Title Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound
Date of disclosure of the study information 2010/01/06
Last modified on 2016/01/31

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Basic information
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
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

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2009 Year 12 Month 31 Day
Last modified on
2016 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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