UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002060 |
|---|---|
| Receipt number | 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 13:53:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002511
