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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003166
Receipt No. R000003375
Scientific Title Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Extended JAPAN-ACS)
Date of disclosure of the study information 2010/02/12
Last modified on 2012/04/17

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Basic information
Public title Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Extended JAPAN-ACS)
Acronym Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Extended JAPAN-ACS)
Scientific Title Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Extended JAPAN-ACS)
Scientific Title:Acronym Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Extended JAPAN-ACS)
Region
Japan

Condition
Condition acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the relationship between coronary plaque regression and cardiovascular prevention in long term follow up of the JAPAN-ACS study. In addition, the objectives of this study are to evaluate the effect of serum lipid levels or different type of statins on cardiovascular prevention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of one offollowing events (composite endpoint)
1.Cardiovascular death
2.Non-fatal Myocardial Infarction (MI)
3.Non-fatal Cerebral Infarction (CI)4.Unstable angina requiring urgent hospitalizations
Key secondary outcomes 1.Composite cardiovascular events
Occurrence of one of following events
Cardiovascular death, Non-fatal MI, Non-fatal CI, Unstable angina requiring hospitalizations, Ischemia-driven coronary revascularization except target lesion revascularization (TLR)

2.Composite coronary heart disease events
Occurrence of one of following events
Coronary heart disease (CHD) death, Non-fatal MI, Unstable angina requiring urgent hospitalizations, Ischemia-driven coronary revascularization except TLR.

3.Composite cerebrovascular events
Occurrence of one of following events
Fatal and Non-fatal stroke, Transient ischemic attack (TIA) requiring hospitalizations.

4.Death events
Occurrence of each following events
All-cause mortality
Cardiovascular death
Cardiac death
CHD death

5.Heart disease events
Occurrence of each following events
Fatal and Non-fatal MI
Non-procedure related MI
Procedure related MI
Unstable angina requiring urgent hospitalizations
Resuscitated cardiac arrest
Hospitalization for heart failure
PCI or CABG
(1)All events of PCI or CABG
(a)TLR
(b)non-TLR
(2)Ischemia-driven PCI or CABG
(a)TLR
(b)non-TLR

6.Cerebrovascular events
Occurrence of each following events
Fatal and Non-fatal stroke
Fatal and Non-fatal CI
(1) Non-procedure related CI
(2) Procedure related CI
Fatal and Non-fatal cerebral hemorrhage
Hospitalization for TIA

7.The other events
Occurrence of each following events
Operation for or rupture of aortic aneurysm
Revascularization for peripheral arterial disease (PAD)
Carotid artery stenting (CAS) or carotid endarterectomy (CEA)
Aortic dissection
Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE)
New occurrence of malignant tumor
Operation for aortic stenosis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were underwent coronary intravascular ultrasound (IVUS) evaluation both at baseline and the follow up period, and whose IVUS data were analyzable in the JAPAN-ACS study.
Key exclusion criteria none
Target sample size 252

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masunori Matsuzaki
Organization Yamaguchi University Graduate School of Medicine
Division name Division of Cardiology, Department of Medicine and Clinical Science
Zip code
Address 1-1-1 Minamikogushi, Ube-city, Yamaguchi, 755-8505
TEL 0836-22-2248
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yumika Fujino
Organization Cardiovascular Research Promotion Unit
Division name Cardiovascular Research Promotion Unit
Zip code
Address 15, Shimogamo Morimoto-cho, Sakyo-ku, Kyoto, JAPAN 606-0805
TEL 075-781-1107
Homepage URL http://www.japan-acs.or.jp/
Email japan-acs.seiken@midinfo.co.jp

Sponsor
Institute Research Institute for Production Development
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 NTT 東日本札幌病院(北海道)、財団法人厚生会仙台厚生病院(宮城県)、秋田県成人病医療センター(秋田県)、順天堂大学医学部附属浦安病院(千葉県)、国家公務員共済組合連合会虎の門病院、順天堂大学医学部附属順天堂医院、東京大学医学部附属病院(東京都)、公立大学法人横浜市立大学附属市民総合医療センター(神奈川県)、岐阜県総合医療センター(岐阜県)、順天堂大学医学部附属静岡病院(静岡県)、愛知医科大学病院、愛知県厚生農業協同組合連合会安城更生病院、名古屋第一赤十字病院、藤田保健衛生大学病院、(愛知県)、市立四日市病院(三重県)、京都大学医学部附属病院(京都府)、大阪市立総合医療センター、国立循環器病センター(大阪府)、独立行政法人労働者健康福祉機構関西労災病院(兵庫県)、和歌山県立医科大学附属病院(和歌山県)、岡山赤十字病院、財団法人倉敷中央病院(岡山県)、医療法人あかね会土谷総合病院、広島市立安佐市民病院、広島市立広島市民病院(広島県)、綜合病院社会保険徳山中央病院、山口大学医学部附属病院(山口県)、独立行政法人国立病院機構浜田医療センター(島根県)、愛媛県立中央病院(愛媛県)、社会保険小倉記念病院、福岡大学病院(福岡県)、社会福祉法人恩賜財団済生会熊本病院(熊本県)、独立行政法人国立病院機構鹿児島医療センター(鹿児島県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.jstage.jst.go.jp/article/circj/76/4/76_825/_article
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 Completed
Date of protocol fixation
2010 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information To verify the relationship between coronary plaque regression and cardiovascular prevention.

Management information
Registered date
2010 Year 02 Month 10 Day
Last modified on
2012 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003375

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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