UMIN-CTR Clinical Trial

Basic information
Public title	The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Acronym	The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Scientific Title	The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Scientific Title:Acronym	The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Region	Japan

Condition
Condition	Ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine the influence of coadministration of PPI (rabeprazole or omeprazole) on the effectiveness of clopidogrel by measuring platelet aggregation.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Platelet aggregation rate after intake of omeprazole or rabeprazole for 14 days
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	After administration of ranitidine 300mg for 14 days, patients receive omeprazole 20mg for 14 days, and then receive ranitidine 300mg for 14 days again. Finally they receive rabeprazole 10mg for 14 days.
Interventions/Control_2	After administration of ranitidine 300mg for 14 days, patients receive rabeprazole 10mg for 14 days, and then receive ranitidine 300mg for 14 days again. Finally they receive omeprazole 20mg for 14 days.
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 are taking clopidogrel and aspirin, and have reflux esophagitis.
Key exclusion criteria	Drug allergy of study drugs; aspirin, clopidogrel, omeprazole, rabeprazole and ranitidine. Severe chronic renal failure Severe liver dysfunction
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kyoichi Middle name Last name Mizuno
Organization	Nippon Medical School Department of Internal Medicine
Division name	Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine
Zip code	113-8603
Address	1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	sigenobu@nms.ac.jp

Public contact
Name of contact person	1st name Shigenobu Middle name Last name Inami
Organization	Nippon Medical School Department of Internal Medicine
Division name	Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine
Zip code	113-8603
Address	1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	sigenobu@nms.ac.jp

Sponsor
Institute	Nippon Medical School Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine
Institute
Department

Funding Source
Organization	Daiichi Sankyo Co.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Center for clinical research
Address	1-1-5 Sendagi Bunkyo-ku, Tokyo
Tel	03-3822-2131
Email	inq-ccr@nms.ac.jp

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	2010 Year 06 Month 01 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	Terminated
Date of protocol fixation	2010 Year 03 Month 05 Day
Date of IRB	2010 Year 02 Month 24 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2011 Year 05 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 16 Day
Date trial data considered complete	2013 Year 12 Month 16 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 05 Month 27 Day
Last modified on	2020 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004441

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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