UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019901 |
|---|---|
| Receipt number | R000022985 |
| Scientific Title | Impact of esomeprazole and vonoprazan on the antiplatelet effect of clopidogrel and prasugrel, with reference to CYP2C19 genotypes |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2016/07/12 14:04:55 |
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Basic information
Public title
Impact of esomeprazole and vonoprazan on the antiplatelet effect of clopidogrel and prasugrel, with reference to CYP2C19 genotypes
Acronym
Impact of PPI on the antipratelet effect of P2Y12 inhibitor
Scientific Title
Impact of esomeprazole and vonoprazan on the antiplatelet effect of clopidogrel and prasugrel, with reference to CYP2C19 genotypes
Scientific Title:Acronym
Impact of PPI on the antipratelet effect of P2Y12 inhibitor
Region
| Japan |
Condition
Condition
Ischemic heart disease and upper gastrointestinal bleeding.
Classification by specialty
| Gastroenterology | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of present study is to investigate the impact of esomeprazol and vonoprazan on the antiplatelet effect of clopidgrel and prasugrel with reference to CYP2C19 genotypes.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is antiplatelet effect with the six regimens as assessed by P2Y12 assay using Verify Now System (Accumetrics, Inc., San Diego, USA) on Day7 of each regimen.
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
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(1) clopidgrel 75 mg once daily (qd) for 7 days.
Subjecs receive six regimens in a crossover manner as (1) to (6). The order of six regimens is randomized. A clinical research coordinator (M. K.) manages the dosing schedule of each subject. Washout interval between regimens is at least 2 weeks
Interventions/Control_2
(2) prasugrel 3.75 mg qd for 7 days
Interventions/Control_3
(3) esomeprazol 20 mg qd and clopidgrel 75 mg once daily (qd) for 7 days
Interventions/Control_4
(4) esomeprazol 20 mg qd and prasugrel 3.75 mg qd for 7 days
Interventions/Control_5
(5) vonoplazan 10 mg and clopidgrel 75 mg once daily (qd) for 7 days
Interventions/Control_6
(6) vonoplazan 10 mg and prasugrel 3.75 mg qd for 7 days
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese adult
Key exclusion criteria
Exclusion criteria are any underlying disease, smoking habit, past or present H. pylori infection, and habitual use of any medicine.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Kagami |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
1-20-1 Handayama, Higasi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
D14029@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Furuta |
Organization
Hamamatsu University School of Medicine
Division name
Center for Clinical Research
Zip code
Address
1-20-1 Handayama, Higasi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
Homepage URL
furuta@hama-med.ac.jp
Sponsor or person
Institute
The First Department of Medicine and the Center for Clinical Research at Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This work was supported by a grant-in-aid from the Ministry of Education, Culture, Sports, Science and Technology of Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2015 | Year | 11 | Month | 24 | 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
| 2015 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 07 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 23 | Day |
Last modified on
| 2016 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022985
