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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041165
Receipt No. R000046995
Scientific Title AFTER: Assessment oF anti-Thrombotic Effects of conventional anti-thrombotic therapy using total thrombus-formation analysis system in transcatheter aortic valve Replacement
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/20

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Basic information
Public title Assessment of anti-thrombotic effects of conventional anti-thrombotic therapy using total thrombus-formation analysis system in transcatheter aortic valve replacement
Acronym AFTER
Scientific Title AFTER: Assessment oF anti-Thrombotic Effects of conventional anti-thrombotic therapy using total thrombus-formation analysis system in transcatheter aortic valve Replacement
Scientific Title:Acronym AFTER
Region
Japan

Condition
Condition Aortic stenosis
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of conventional anti-thrombotic therapy after TAVI using Total Thrombus-Formation Analysis System
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Anti-thrombotic abilities
Key secondary outcomes Mortality, bleeding events, thrombotic events

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 Patients who can undergo TAVI via transfemoral approach
Key exclusion criteria Patients who met the following criteria were excluded from this study; 1) TAVI using alternative access, 2) patients who cannot take anti-thrombotic therapy prior to TAVI, 3) TAVI needed more than two valve, 4) TAVI needed emergent surgical conversion, 5) new-onset atrial fibrillation, 6) TAVI in SAV, 7) patients refused to participate this study.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Kozuma
Organization Teikyo University
Division name Department of Internal Medicine, Division of Cardiology
Zip code 173-8606
Address 2-11-1, Kaga, Itabashi-ku
TEL 0339641211
Email PXE00364@nifty.com

Public contact
Name of contact person
1st name Hirofumi
Middle name
Last name Hioki
Organization Teikyo University
Division name Department of Internal Medicine, Division of Cardiology
Zip code 173-8606
Address 2-11-1, Kaga, Itabashi-ku
TEL 0339641211
Homepage URL
Email hioki.teikyo@gmail.com

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
Tel 0339647256
Email turb-office@teikyo-u.ac.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
2020 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 Open public recruiting
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 06 Month 25 Day
Anticipated trial start date
2020 Year 06 Month 25 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing to disclose as other related information

Management information
Registered date
2020 Year 07 Month 20 Day
Last modified on
2020 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046995

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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