UMIN-CTR Clinical Trial

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
Email	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
Email	t-aoyama@rs.noda.tus.ac.jp

Sponsor
Institute	Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012733