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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019901
Receipt No. 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

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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
Email 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
Email furuta@hama-med.ac.jp

Sponsor
Institute The First Department of Medicine and the Center for Clinical Research at Hamamatsu University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022985

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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