UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of esomeprazole and vonoprazan on the antiplatelet effect of clopidogrel and prasugrel, with reference to CYP2C19 genotypes
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takuma Kagami
Organization	Hamamatsu University School of Medicine
Division name	First Department of Medicine
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	Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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