UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047650 |
|---|---|
| Receipt number | R000054120 |
| Scientific Title | Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events |
| Date of disclosure of the study information | 2022/05/30 |
| Last modified on | 2022/05/04 20:24:39 |
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Basic information
Public title
Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Acronym
Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Scientific Title
Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Scientific Title:Acronym
Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the changes of activated clotting time during percutaneous coronary intervention (PCI)and adverse clinical events after PCI in patients who were prescribed direct oral anticoagulant
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prognosis from the end of percutaneous coronary revascularization to 30 days (bleeding events, embolic events)
Key secondary outcomes
Kinetic changes in activated coagulation time during percutaneous coronary revascularization (at the start and 30 minutes after the procedure)
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent PCI in the cardiovascular centers in Japan between February 2017 and April 2018.
Key exclusion criteria
Patients receiving warfarin at the time of percutaneous coronary intervention (PCI) and patients whose activated clotting time was not measured at the time of PCI initiation were excluded.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Jujo |
Organization
Tokyo women medical university
Division name
Department of Cardiology
Zip code
162-0054
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
81-3-3353-8111
juken1123@mac.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shibahashi |
Organization
Tokyo Womens Medical University
Division name
Department of Cardiology
Zip code
162-0054
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
81-3-3353-8111
Homepage URL
shiabahashi.e@gmail.com
Sponsor or person
Institute
Tokyo women medical 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
Nishiarai hospital
Address
1-12-12, Nishiaraihoncho, Adachi-ku, Tokyo, Japan
Tel
03-5647-1700
shiabahashi.e@gmail.com
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 | 05 | 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
246
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
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: cohort study
All patients who visited the relevant center between February 2017 and April 2018 and met the selection criteria
Management information
Registered date
| 2022 | Year | 05 | Month | 04 | Day |
Last modified on
| 2022 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054120
