UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003407
Receipt No. R000003543
Scientific Title The Influence of H2 blocker on the Antiplatelet Effect of Clopidogrel
Date of disclosure of the study information 2010/03/30
Last modified on 2012/10/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Influence of H2 blocker on the Antiplatelet Effect of Clopidogrel
Acronym The Influence of H2 blocker on the Antiplatelet Effect of Clopidogrel
Scientific Title The Influence of H2 blocker on the Antiplatelet Effect of Clopidogrel
Scientific Title:Acronym The Influence of H2 blocker on the Antiplatelet Effect of Clopidogrel
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the influence of H2 blocker famotidine on the antiplatelet effect of clopidogrel.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximal Platelet Aggregation Rate after intake of H2 blocker
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 patients taking H2 blocker famotidine, on low-dose (81-100 mg) aspirin and 75 mg of clopidogrel
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

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients on low-dose (81-100 mg) aspirin and 75 mg of clopidogrel
Key exclusion criteria 1) contraindicative patients of aspirin and clopidogrel, 2) patients with warfarin, 3) patients with thrombolytic therapy within 2 weeks, and 4) patients taking ticlopidine, cilostazole or dipyridamole within 1 month 5)chronical renal failure(Cre>1.5)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro kato
Organization Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address
TEL 075-751-4255
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2010 Year 03 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 Completed
Date of protocol fixation
2010 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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

Management information
Registered date
2010 Year 03 Month 30 Day
Last modified on
2012 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003543

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.