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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003668
Receipt No. R000004441
Scientific Title The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Date of disclosure of the study information 2010/06/01
Last modified on 2020/12/04

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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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