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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002678
Receipt No. R000003258
Scientific Title Effect of Pitavastatin on Coronary Fibrous-cap Thickness - Assessment by Fourier-Domain Optical Coherence Tomography (ESCORT)
Date of disclosure of the study information 2009/11/01
Last modified on 2017/11/02

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Basic information
Public title Effect of Pitavastatin on Coronary Fibrous-cap Thickness - Assessment by Fourier-Domain Optical Coherence Tomography (ESCORT)
Acronym Effect of PitavaStatin on Coronary Fibrous-cap Thickness - Assessment by Fourier-Domain Optical CoheRence Tomography (ESCORT)
Scientific Title Effect of Pitavastatin on Coronary Fibrous-cap Thickness - Assessment by Fourier-Domain Optical Coherence Tomography (ESCORT)
Scientific Title:Acronym Effect of PitavaStatin on Coronary Fibrous-cap Thickness - Assessment by Fourier-Domain Optical CoheRence Tomography (ESCORT)
Region
Japan

Condition
Condition Patients with acute coronary syndrome with a history of having undergone successful percutaneous coronary intervention
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To investigate the significance of aggressive LDL-C-lowering therapy in acute coronary syndrome subjects by OCT (Optical Coherence Tomography)
2) To investigate the correlations between coronary fibrous-cap thickness and lipid or inflammatory markers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percent change in coronary fibrous-cap thickness
Key secondary outcomes 1) Change in coronary fibrous-cap thickness
2) Absolute and percent change of the lipid core size
3) Absolute and percent changes of the serum LDL-C, TC, TG and HDL-C
4) Absolute and percent changes of the serum hs-CRP, MMP-9 and oxLDL
5) Correlation between percent changes of the serum lipid parameters and absolute/percent change of the coronary fibrous-cap thickness
6) Correlation between percent changes of the serum hs-CRP, MMP-9 and oxLDL and absolute/percent change of the coronary fibrous-cap thickness
7) Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, Q-wave or non-Q-wave MI, PCI, or coronary artery bypass grafting)
8) All-cause mortality
9) Rate of adverse reactions
10) Changes of the laboratory test results

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 4 mg pitavastatin daily started within 24 hours of PCI and administered for a period of 36 weeks
Interventions/Control_2 4 mg pitavastatin daily administered from 3 weeks to 36 weeks after PCI
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with acute coronary syndrome (defined as ST-segment elevation acute myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina). Patients who meet at least two of the following criteria within 7 days prior to admission:
1. ECG changes of acute coronary ischemia
2. SerumCK level more than 2 times the upper limit of normal, serum CK-MB or troponin (T/I) over the above upper limit of normal, or positivity for serum troponin T by a rapid, qualitative assay
3. Clinical history or pathological findings of acute myocardial infarction.
2) Patients who have at least one coronary plaque involving 25% or more of the stenosis (at the culprit lesion, the plaque needs to be 10 mm or more away from the PCI lesion)
3) Patients with hypercholesterolemia as defined by either of the criteria below
1.LDL-C>=140mg/dL
2.LDL-C>=100mg/dL and patients who are judged by the investigator as needing cholesterol-lowering treatment by the investigator
4) Patients 20 years old or older at the time of provision of consent
5) Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study
Key exclusion criteria 1) Target PCI lesion is graft stenosis or in-stent restenosis
2) Patients who had undergone previous PCI for the lesion under evaluation.
3) Patients who have plaque in a non-culprit site on the PCI vessel that might call for PCI during the treatment period (non-culprit lesion is unrestricted)
4) Patients already receiving lipid lowering agents (HMG-CoA reductase inhibitors [statins], fibrates, probucol, nicotinic acid, anion exchange resins, or ezetimib)
5) Patients with familial hypercholesterolemia
6) Patients with cardiogenic shock
7) Patients on cyclosporine therapy
8) Patients with a history of hypersensitivity to any of the components of the product
9) Patients with liver dysfunction (ALT[GPT] >= 100IU), biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus
10) Pregnant and possibly pregnant women, lactating women
11) Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or on maintenance dialysis
12) Patients who are judged by the principal or other investigator to be ineligible for enrollment in the study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Akasaka
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL 073-441-0621
Email akasat@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Nishiguchi
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL 073-447-2300(2318)
Homepage URL
Email t-nsgc@wakayama-med.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.imaging.onlinejacc.org/content/early/2017/09/09/j.jcmg.2017.07.011?sso=1&sso_redirect_cou
Number of participants that the trial has enrolled
Results
Between baseline and 3-week follow-up, fibrous cap thickness increased in the early statin group (140um to 160um, p=0.017) but decreased in the late statin group (135um to 130um, p=0.020). The percentage of increase in fibrous cap thickness between baseline and 3-week follow-up was significantly greater in the early statin group compared with the late statin group (8.3% vs. -5.8%, p<0.001). Between baseline and 36-week follow-up, fibrous cap thickness increased comparably in the two groups.

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 Completed
Date of protocol fixation
2009 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
2014 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 01 Day
Date analysis concluded
2016 Year 12 Month 28 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 27 Day
Last modified on
2017 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003258

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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