UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041165 |
|---|---|
| Receipt number | 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 | 2022/08/04 16:29:09 |
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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
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
hioki.teikyo@gmail.com
Sponsor or person
Institute
Teikyo University
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
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
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
Completed
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
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046995
