UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis
Acronym	Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis
Scientific Title	Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis
Scientific Title:Acronym	Multicenter observational study to determine the optimal duration of anticoagulation in patients with pulmonary thromboembolism and deep vein thrombosis
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 Daisuke Middle name Last name Fukamachi
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
Email	fukamachi.daisuke@nihon-u.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Fukamachi
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
Email	fukamachi.daisuke@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address	30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
Tel	03-3972-8111
Email	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	Open public recruiting
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	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054354

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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