UMIN-CTR Clinical Trial

Public title

Genomic analysis approach to avoid from complications from proton pump inhibitor and warfarin combination therapy after open heart surgery

Acronym

Genomic analysis for order made prescription after open heart surgery

Scientific Title

Genomic analysis approach to avoid from complications from proton pump inhibitor and warfarin combination therapy after open heart surgery

Scientific Title:Acronym

Genomic analysis for order made prescription after open heart surgery

Region

Japan

Condition

ischemic heart disease, heart valve disease, atrial fibrillation

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

genotyping about CYP2C9,VKORC1 and CYP2C19 of patient prescribed both warfarin and proton pump inhibitor, and measure value of INR, concentration in blood of warfarin and proton pump inhibitor, establish selection method about appropriate dose of warfarin and type of protonpump inhibitor in each genotype.

Basic objectives2

Pharmacodynamics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

INR value is 3.5 or more.
INR value is 1.5 below even if administrated 5mg of warfarin
occurring bleeding event
occurring thromboembolic event

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

must be administrated warfarin and proton pump inhibitor after open heart surgery

Key exclusion criteria

none

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Kimura Haruka

Organization

Nihon university school of medicine

Division name

Cardiovascular surgery

Zip code

Address

30-1 Oyagutikamityou Itabashi-ku Tokyo, Japan

TEL

0339728111

Email

permanentfixture@gmail.com

Name of contact person

1st name
Middle name
Last name	Kimura Haruka

Organization

Nihon university school of medicine

Division name

Cardiovascular surgery

Zip code

Address

30-1 Oyagutikamityou Itabashi-ku Tokyo, Japan

TEL

03-3972-8111

Homepage URL

Email

permanentfixture@gmail.com

Institute

Nihon university school of medicine

Institute

Department

Personal name

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Sekino clinical Pharmacology Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

04

Month

30

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Main results already published

Date of protocol fixation

2010

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In this observational prospective study, the CYP2C9, CYP2C19, and VKORC1 genotypes of 78 patients were analyzed. After excluding cases with *1/*3 of the CYP2C9 genotype and those with C/T of the VKORC1 genotype, 60 patients were assigned to warfarin + Rabeplazole (RB group, 30 cases) or warfarin + Lansoplazole (LP group, 30 cases). Warfarin was started with an initial dose of 3mg, and INR values were measured on Days 4, 8, 14, 28, and 56. There was no significant difference in median warfarin dose between the LP group (2.5mg/day) and RB group (3.0mg/day), (P=0.88). The time in the therapeutic range (Rosendaal) was significantly higher in the RB group (83.68%) than in the LP group (49.44%), and the TOR (Time in Over-Range) was significantly higher in the LP group (41.88%) than in the RB group (0.00%). In the LP group, TTR values were higher in CYP2C19 Extensive Metabolizers (EMs) than in Intermediate Metabolizers (IMs) and Poor Metabolizers (PMs), but there was no statistically significant difference between them. Conversely, in the RB group, there was no difference in the values of any CYP2C19 genotype. A multivariate analysis showed that high age and low TTR were risk factors for bleeding.

Registered date

2012

Year

04

Month

24

Day

Last modified on

2014

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009204