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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002060
Receipt No. R000002511
Scientific Title The Influence of Proton Pump Inhibitors on the Antiplatelet Effect of Clopidogrel
Date of disclosure of the study information 2009/06/10
Last modified on 2012/10/01

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Basic information
Public title The Influence of Proton Pump Inhibitors on the Antiplatelet Effect of Clopidogrel
Acronym The Influence of Proton Pump Inhibitors on the Antiplatelet Effect of Clopidogrel
Scientific Title The Influence of Proton Pump Inhibitors on the Antiplatelet Effect of Clopidogrel
Scientific Title:Acronym The Influence of Proton Pump Inhibitors on the Antiplatelet Effect 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 proton pump inhibitor (PPI) omeprazole or rabeprazole on the antiplatelet effect of clopidogrel.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximal Platelet Aggregation Rate after intake of PPI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 the change of administration from 20 mg of omeprazole to 10 mg of rabeprazole
Interventions/Control_2 the change of administration from 10 mg of rabeprazole to 20 mg of omeprazole
Interventions/Control_3 control
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 taking omeprazole or rabeprazole, on low-dose (81-100 mg) aspirin and 75 mg of clopidogrel
Key exclusion criteria 1) contraindicative patients of aspirin and clopidogrel, 2) patients with warfarin, 3) patients with thrombolytic therapy within 2 weeks, and 4) patients taking ticlopidine, cilostazole or dipyridamole within 1 month
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-751-4254
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshikazu Jinnai
Organization Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-751-4255
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 10 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 Completed
Date of protocol fixation
2009 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2010 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2012 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002511

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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