UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005375
Receipt number R000006379
Scientific Title Japanese Clopidogrel Hyporesponsiveness in Patients with Coronary Artery Disease after Undergoing Stent Implantation (j-CHIPS Study).
Date of disclosure of the study information 2011/04/05
Last modified on 2011/10/06 10:49:47

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Basic information

Public title

Japanese Clopidogrel Hyporesponsiveness in Patients with Coronary Artery Disease after Undergoing Stent Implantation (j-CHIPS Study).

Acronym

j-CHIPS Study

Scientific Title

Japanese Clopidogrel Hyporesponsiveness in Patients with Coronary Artery Disease after Undergoing Stent Implantation (j-CHIPS Study).

Scientific Title:Acronym

j-CHIPS Study

Region

Japan


Condition

Condition

Coronary artery disease

Classification by specialty

Cardiology Cardiovascular surgery Laboratory medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The main objective of this study is to develop a technique to monitor hypo-responsiveness to a thienopyridine antiplatelet drug "Clopidogrel" in Japanese patients with the coronary heart disease after stent implantation who received clopidgrel and aspirin. For the purpose, the cut-off value of Clopidogrel hypo-responsiveness and the frequency are estimated, by using VerifyNow System (whole blood aggreggometry made by accumetrics) mainly.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Estimation of Cut-off value of clopidogrel low-responder using whole blood aggregometry

Key secondary outcomes

(1). to analyze the relationship between gene polymorphisms such as CYP2C19 or ABCB-1 and the responsivness to clopidogrel, (2). to analyze the patients characteristics associated with the responsiveness to Clopidgrel, and (3). to estimate the cut-off value of bleeding events (TIMI Classification: Major or Minor bleeding)


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

1) Patients with coronary artery disease including ACS , who will be or has been taking clopidgrel (75 mg/day) and a low dose of aspirin.
2) Patients undergoing possible percutaneous coronary intervention (stent implantation).
3) Patients whose clinical laboratory test results are within the following ranges;
Ht: 25-52%
Platelet:119000-502000 /ul
4) Patients who will voluntarily give written informed consent before participating in this study

Key exclusion criteria

1) Patients who will undergo an operation with bleeding.
2) Patients taking the following drugs;
Warfarin, thrombolytics (tPA), etc.
Other antiplatelet than Aspirin, Cilostazol, Clopidogrel (Dipyridamole, Sarpogrelate, Beraprost, etc.)
3) Patients of the taboo on the package of clopidogrel or aspirin.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakatsu Nishikawa

Organization

Mie University Faculty of Mdicine

Division name

Institute of Human Research Promotion and Drug Development

Zip code


Address

2-174, Edobashi, Tsu, Mie, 514-8507

TEL

059-231-5431

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuki Nishimura

Organization

Mie University Hospital

Division name

Clinical Research Support Center

Zip code


Address

2-174, Edobashi, Tsu, Mie 514-8507

TEL

059-231-5278

Homepage URL


Email

ynishimura@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

NPO Mie Clinical Trials Support Network

Institute

Department

Personal name



Funding Source

Organization

Daiichi-Sankyo Co. Ltd., Medico's Hirata Inc., Accumetrics Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

厚生会 仙台厚生病院(宮城県)、帝京大学医学部附属病院(東京都)、日本大学医学部附属板橋病院(東京都)、日本医科大学(東京都)、横浜市立大学附属市民総合医療センター(神奈川県)、神奈川県立循環器呼吸器病センター(神奈川県)、済生会横浜南部病院(神奈川県)、藤沢市民病院(神奈川県)、三重大学医学部附属病院(三重県)、三重ハートセンター(三重県)、りんくう総合医療センター市立泉佐野病院(大阪府)、神戸大学医学部附属病院(兵庫県)、倉敷中央病院(岡山県)、社会保険小倉記念病院(福岡県)、熊本大学医学部附属病院(熊本県)、済生会熊本病院(熊本県)、熊本中央病院(熊本県)


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 05 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

Open public recruiting

Date of protocol fixation

2010 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cut-off value of clopidogrel low-responder.
Relationships between the gene polymorphisms of metabolic enzymes such as CYP2C19 or ABCB-1.
Relationship patients' background.
Threshold of bleeding event.
Correlation of VerifyNow P2Y12 and other platelet function tests.


Management information

Registered date

2011 Year 04 Month 04 Day

Last modified on

2011 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006379


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name