UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048783 |
|---|---|
| Receipt number | R000055457 |
| Scientific Title | Impact of hemostatic function assessed by Total Thrombus-formation Analysis System (T-TAS01) on bleeding events during transcatheter aortic valve replacement |
| Date of disclosure of the study information | 2022/08/30 |
| Last modified on | 2023/08/30 10:36:04 |
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Basic information
Public title
Impact of hemostatic function assessed by Total Thrombus-formation Analysis System (T-TAS01) on bleeding events during transcatheter aortic valve replacement
Acronym
COFFEESHOPS
Scientific Title
Impact of hemostatic function assessed by Total Thrombus-formation Analysis System (T-TAS01) on bleeding events during transcatheter aortic valve replacement
Scientific Title:Acronym
COFFEESHOPS
Region
| Japan |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical study involves patients undergoing transcatheter aortic valve replacement as a treatment for aortic stenosis. The purpose of the study is to evaluate whether the anti-thrombotic therapy (blood thinning medication) taken by patients undergoing transcatheter aortic valve replacement is effective in inhibiting the process of blood clot formation before and after treatment. By accumulating this data, we will identify safer and more effective antithrombotic therapy for transcatheter aortic valve replacement in Japanese patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PL-AUC10, AR-OT and AR-AUC30, perioperative and post-discharge bleeding events: degree of bleeding, presence and volume of blood transfusion, unanticipated withdrawal of antithrombotic therapy, vascular complications, perioperative and Post-discharge embolic events: myocardial infarction, stroke death, in-hospital death and post-discharge death.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with severe aortic stenosis.
Key exclusion criteria
Exclusion criteria were (1) cases in which antithrombotic therapy could not be introduced preoperatively, and (2) cases in which consent to participate in the study could not be obtained. The exclusion criteria for analysis were (1) TAVI cases requiring more than two valve implantations intraoperatively, (2) cases requiring unplanned coronary revascularization or open chest surgery intraoperatively, and (3) cases in which new atrial fibrillation developed during hospitalization.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Katayama |
Organization
Teikyo university
Division name
Internal medicine
Zip code
173-8605
Address
2-11-1 Kaga Itabashi-ku, Tokyo 173-8605, Japan
TEL
0339641211
taiga.k1202@gmail.com
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Katayama |
Organization
Teikyo university
Division name
Internal medicine
Zip code
173-8605
Address
2-11-1 Kaga Itabashi-ku, Tokyo 173-8605, Japan
TEL
0339641211
Homepage URL
taiga.k1202@gmail.com
Sponsor or person
Institute
Teikyo university
Institute
Department
Personal name
Funding Source
Organization
Teikyo University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo university
Address
2-11-1 Kaga Itabashi-ku, Tokyo 173-8605, Japan
Tel
03-3964-7256
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
| 2022 | Year | 08 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055457
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
