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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007826
Receipt No. R000009204
Scientific Title Genomic analysis approach to avoid from complications from proton pump inhibitor and warfarin combination therapy after open heart surgery
Date of disclosure of the study information 2012/04/30
Last modified on 2014/04/25

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Basic information
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
Condition ischemic heart disease, heart valve disease, atrial fibrillation
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
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

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 Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

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

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

Research contact person
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

Public contact
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

Sponsor
Institute Nihon 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 Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Sekino clinical Pharmacology Clinic
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
2012 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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 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
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.

Management information
Registered date
2012 Year 04 Month 24 Day
Last modified on
2014 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009204


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