UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010881 |
|---|---|
| Receipt number | R000012733 |
| Scientific Title | Study on influence of drugs on antiplatelet effects of aspirin. |
| Date of disclosure of the study information | 2013/06/05 |
| Last modified on | 2022/02/08 14:31:44 |
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Basic information
Public title
Study on influence of drugs on antiplatelet effects of aspirin.
Acronym
Study on influence of drugs on antiplatelet effects of aspirin.
Scientific Title
Study on influence of drugs on antiplatelet effects of aspirin.
Scientific Title:Acronym
Study on influence of drugs on antiplatelet effects of aspirin.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate influence of nonsteroidal anti-inflammatory drugs, health food, selective serotonin reuptake inhibitor (SSRI),
or noradrenergic and specific serotonergic antidepressant (NaSSA) on antiplatelet effect of aspirin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Platelet aggregation activity(Platelet Aggregation Threshold Index:PATI)
Key secondary outcomes
Serum thromboxane B2 concentration
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy volunteers.
2)Subjects who signed, based on his/her free will, to the clinical trial agreement with full understanding of the purpose of this conducted trial and its insights.
Key exclusion criteria
1)Subjects who have donated 200 mL blood within 1 month, or 400 mL blood within 3 month.
2)Subjects who have taken aspirin or drugs with antiplatelet effect within 1 week.
3)Subjects with hypertension or hypotension.
4)Subjects with poor condition on a blood collecting day.
5)Subjects whom the doctor considered to be unsuitable for this study.
6)Subjects who are unable to put restrictions on diets (ex. foods and drinks are prohibited within 4 hours prior to blood collection, high fat meals should be avoided since 1 day before blood collection).
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Aoyama |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-3659
t-aoyama@rs.noda.tus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Aoyama |
Organization
Tokyo University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL
04-7121-3659
Homepage URL
t-aoyama@rs.noda.tus.ac.jp
Sponsor or person
Institute
Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
東京理科大学薬物治療学研究室
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 05 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
To investigate influence of nonsteroidal anti-inflammatory drugs or statins on antiplatelet effect of aspirin.
Platelet aggregation activity(Platelet Aggregation Threshold Index:PATI)
Management information
Registered date
| 2013 | Year | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012733
