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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008239
Receipt No. R000009717
Scientific Title Impact of Endothelial Dysfunction on Residual Platelet Aggregability after Dual Anti-platelet Therapy with Aspirin and Clopidogrel in Stable Patients with Coronary Artery Disease
Date of disclosure of the study information 2012/07/01
Last modified on 2014/06/02

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Basic information
Public title Impact of Endothelial Dysfunction on Residual Platelet Aggregability after Dual Anti-platelet Therapy with Aspirin and Clopidogrel in Stable Patients with Coronary Artery Disease
Acronym Endothelial Function in Dual Anti-platelet Therapy
Scientific Title Impact of Endothelial Dysfunction on Residual Platelet Aggregability after Dual Anti-platelet Therapy with Aspirin and Clopidogrel in Stable Patients with Coronary Artery Disease
Scientific Title:Acronym Endothelial Function in Dual Anti-platelet Therapy
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess the impact of endothelial dysfunction on residual platelet aggregability after dual antiplatelet therapy with aspirin and clopidogrel.
Basic objectives2 Others
Basic objectives -Others Assessment of pathophysiology.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes endothelial function and residual platelet aggregability
Key secondary outcomes

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

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We first registered stable patients with CAD who were consulted to Kumamoto University Hospital. CAD was defined as the presence of angina history or myocardial ischemia by stress tests with the presence of coronary stenosis more than 50% of the vessel diameter detected by coronary angiography or computed tomography coronary angiography scan, or history of myocardial infarction, PCI, or coronary artery bypass grafting.
Key exclusion criteria 1:acute coronary syndromes
2:known allergy to clopidogrel
3:thrombocytopenia
4:patients with collagen disease
5:infection
6:severe liver dysfunction
7:malignant diseases
8:patients were treated with ticlopidine, cilostazol and sarpogrelate
9:hemodialysis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL 81-96-373-5175
Email ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Fujisue
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL 81-96-373-5175
Homepage URL
Email fujisues@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization the Ministry of Education, Science, and Culture in Japan
Organization
Division
Category of Funding Organization
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
2012 Year 07 Month 01 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
2008 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We identified CYP2C19 genotypes in stable-CAD patients and enrolled 103 patients without CYP2C19 loss-of-function allele. All patients received aspirin and clopidogrel. The correlation between residual platelet aggregability and endothelial function by RH-PAT were assessed.

Management information
Registered date
2012 Year 06 Month 24 Day
Last modified on
2014 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009717

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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