UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009019 |
|---|---|
| Receipt number | R000010580 |
| Scientific Title | Evaluate the Interaction Between Antiplatelet Effect of Clopidogrel and Proton Pump Inhibitor |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2012/10/01 18:57:08 |
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Basic information
Public title
Evaluate the Interaction Between Antiplatelet Effect of Clopidogrel and Proton Pump Inhibitor
Acronym
Interaction of Clopidogrel and PPI
Scientific Title
Evaluate the Interaction Between Antiplatelet Effect of Clopidogrel and Proton Pump Inhibitor
Scientific Title:Acronym
Interaction of Clopidogrel and PPI
Region
| Japan |
Condition
Condition
ischemic heart disease, gastric ulcer, Gastroesophageal Reflux Disease
Classification by specialty
| Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluate the effect of PPI (Omeprazole and Esomeprazole) to antiplatelet effect of clopidogrel in ischemic heart disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antiplatelet effect of clopidogrel evaluated by VerifyNow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Taking omeprazole
Interventions/Control_2
Taking eomeprazole
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients taking DAPT (aspirin and clopidogrel) due to ischemic heart disease, and taking Proton pump inhibitor due to peptic ulcer or gastroesophageal Reflux Disease
Key exclusion criteria
Contraindication of aspirin and clopidogrel
Patients taking Warfarin
Patients performed thrombolysis within 2 weeks
Patients taking other antiplatelet agents
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-4254
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Tazaki |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-4254
Homepage URL
jun1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 01 | Day |
Last modified on
| 2012 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010580
