UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003166
Receipt number 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 11:54:17

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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 or person

Institute

Research Institute for Production Development

Institute

Department

Personal name



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

Value
https://center6.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