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

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 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


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

Value
https://center6.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