Unique ID issued by UMIN | UMIN000005375 |
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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 |
Japanese Clopidogrel Hyporesponsiveness in Patients with Coronary Artery Disease after Undergoing Stent Implantation (j-CHIPS Study).
j-CHIPS Study
Japanese Clopidogrel Hyporesponsiveness in Patients with Coronary Artery Disease after Undergoing Stent Implantation (j-CHIPS Study).
j-CHIPS Study
Japan |
Coronary artery disease
Cardiology | Cardiovascular surgery | Laboratory medicine |
Others
YES
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.
PK,PD
Exploratory
Pragmatic
Not applicable
Estimation of Cut-off value of clopidogrel low-responder using whole blood aggregometry
(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)
Observational
Not applicable |
Not applicable |
Male and Female
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
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.
1000
1st name | |
Middle name | |
Last name | Masakatsu Nishikawa |
Mie University Faculty of Mdicine
Institute of Human Research Promotion and Drug Development
2-174, Edobashi, Tsu, Mie, 514-8507
059-231-5431
1st name | |
Middle name | |
Last name | Yuki Nishimura |
Mie University Hospital
Clinical Research Support Center
2-174, Edobashi, Tsu, Mie 514-8507
059-231-5278
ynishimura@clin.medic.mie-u.ac.jp
NPO Mie Clinical Trials Support Network
Daiichi-Sankyo Co. Ltd., Medico's Hirata Inc., Accumetrics Inc.
Profit organization
Japan
NO
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)
2011 | Year | 04 | Month | 05 | Day |
Unpublished
Open public recruiting
2010 | Year | 12 | Month | 04 | Day |
2011 | Year | 04 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
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.
2011 | Year | 04 | Month | 04 | Day |
2011 | Year | 10 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006379
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