UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008239 |
|---|---|
| Receipt number | 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 11:12:47 |
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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
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
fujisues@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009717
