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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034196
Receipt No. R000038984
Official scientific title of the study Evaluation of Blood Thrombogenicity in Acute Myocardial Infarction (EBTAMI) Study
Date of disclosure of the study information 2018/09/19
Last modified on 2018/09/19

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Basic information
Official scientific title of the study Evaluation of Blood Thrombogenicity in Acute Myocardial Infarction (EBTAMI) Study
Title of the study (Brief title) EBTAMI Study
Region
Japan

Condition
Condition Prospective observational study
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the mechanism of acute coronary syndrome onset, measure the blood thrombogenicity in acute MI, unstable angina, and stable coronary artery disease patients.
Basic objectives2 Others
Basic objectives -Others pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood thrombogenicity measured by T-TAS
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria acute myocardial infarction, unstable angina, or stable coronary artery disease patients
Key exclusion criteria none
Target sample size 300

Research contact person
Name of lead principal investigator Yasunori Ueda
Organization National Hospital Organization, Osaka National Hospital
Division name Cardiovascular Division
Address 2-1-14 Hoenzaka, Chuo-ku
TEL +81669421331
Email ueda@onh.go.jp

Public contact
Name of contact person Yasunori Ueda
Organization National Hospital Organization, Osaka National Hospital
Division name Cardiovascular Division
Address 2-1-14 Hoenzaka
TEL +81669421331
Homepage URL
Email ueda@onh.go.jp

Sponsor
Institute National Hospital Organization, Osaka National Hospital
Institute
Department

Funding Source
Organization Pfizer, Bayer, Daiichi-Sankyo, Astellas, Shionogi
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 09 Month 19 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 16 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information The blood thrombogenicity will be measured by T-TAS in acute myocardial infarction, unstable angina and stable coronary artery disease patients.

Management information
Registered date
2018 Year 09 Month 19 Day
Last modified on
2018 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038984

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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