UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014739 |
|---|---|
| Receipt number | R000017103 |
| Scientific Title | a cohort study to verify the influences of CYP2C19 phenotype on antiplatelet effectiveness in hemodialysis patients with CAD and/or PAD |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2023/11/29 11:56:52 |
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Basic information
Public title
a cohort study to verify the influences of CYP2C19 phenotype on antiplatelet effectiveness in hemodialysis patients with CAD and/or PAD
Acronym
HD-DAPT
Scientific Title
a cohort study to verify the influences of CYP2C19 phenotype on antiplatelet effectiveness in hemodialysis patients with CAD and/or PAD
Scientific Title:Acronym
HD-DAPT
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Peripheral Artery Disease
End-Stage Renal Disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the relatinonship between platelet function and CYP2C19 phenotype and to examine how it influence on cardiovascular events in hemodialysis patients with CAD and/or PAD by using VASP-PRI/VerifyNow system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MACE(cardiovascular death, MI, Stroke, TIA),Major bleeding,Other adverse events
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
Hemodialysis patients under taking double antiplatelet therapy or planning it
Key exclusion criteria
Inappropriate patients for this study judged by the physicians.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakakibara |
Organization
Nagoya Kyoritsu Hospital
Division name
Department of Cardiology
Zip code
4540933
Address
1-172,Hokke,Nakagawa,Nagoya,454-0933 Japan
TEL
052-362-5151
tsakakibara@kaikou.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sakakibara |
Organization
Nagoya Kyritsu Hospital
Division name
Department of Cardiology
Zip code
4540933
Address
1-172,Hokke,Nakagawa,Nagoya,454-0933 Japan
TEL
052-362-5151
Homepage URL
tsakakibara@kaikou.or.jp
Sponsor or person
Institute
Nagoya Kyoritsu Hospital, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO.LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya Kyoritsu Hospital, Department of Cardiology
Address
1-172,Hokke,Nakagawa,Nagoya,454-0933 Japan
Tel
052-362-5151
kogure_ayaka@ethic.co.jp
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
| 2014 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
･the relationship PRU value and risk of cardiovascular events
･How hemodialysis influence on effect of antiplatelet medicine
Management information
Registered date
| 2014 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017103
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
