UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047671 |
|---|---|
| Receipt number | R000054354 |
| Scientific Title | Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2024/01/16 22:51:06 |
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Basic information
Public title
Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis
Acronym
SAKURA PE/DVT REGISTRY
Scientific Title
Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis
Scientific Title:Acronym
SAKURA PE/DVT REGISTRY
Region
| Japan |
Condition
Condition
pulmonary thromboembolism and deep vein thrombosis
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify patients in whom the duration of intensified therapy and the duration of chronic phase treatment can be shortened while balancing the risk of bleeding with the prevention of recurrent pulmonary thromboembolism and deep vein thrombosis with anticoagulant drugs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of thrombus resolution
Key secondary outcomes
･ Onset/exacerbation of symptomatic pulmonary embolism (PE)
･ Onset/exacerbation of symptomatic deep vein thrombosis (DVT)
･ Major bleeding event (ISTH bleeding criteria)
･ Non-major bleeding event (bleeding events that do not correspond to major bleeding)
･ Recurrence/exacerbation of symptomatic venous thromboembolism or bleeding event during the initial strengthening treatment period
･ Acute coronary syndrome
･ Cerebral infarction
･ VTE related death
･ Cardiovascular death
･ All deaths
･ Relationship between change in D-dimer and recurrence
･ Relationship between blood levels of anti-factor Xa activity, rate of thrombus resolution, and bleeding events
･ Comparison of examples of treatment continuation/discontinuation or termination events
･ Serious adverse events
･ Relationship between changes in bronchial artery diameter and improvement in pulmonary function as quantitatively assessed using Iodine Density Perfusion Maps
･ Relationship between computed tomography parameters and rate of thrombus resolution
･ Relationship between evaluation of Radwisp and pulmonary thromboembolism patients
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 diagnosed with pulmonary thromboembolism and deep vein thrombosis
Key exclusion criteria
1. Persons who have difficulty obtaining consent in person
2. Persons who have refused to participate in this study
3. In addition, patients determined to be inappropriate for the study by the attending doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Migita |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
migita.shohei@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Guerbet Japan Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-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 | 05 | Month | 06 | 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
| 2021 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis
Management information
Registered date
| 2022 | Year | 05 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054354
| Research Plan | |
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| 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 |
