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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025072
Receipt No. R000028814
Scientific Title Japanese registry of Rivaroxaban effectiveness & safety for the prevention of recurrence in patients with Deep Vein Thrombosis and Pulmonary Embolism
Date of disclosure of the study information 2016/11/30
Last modified on 2019/06/04

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Basic information
Public title Japanese registry of Rivaroxaban effectiveness & safety for the prevention of recurrence in patients with Deep Vein Thrombosis and Pulmonary Embolism
Acronym J'xactly Study
Scientific Title Japanese registry of Rivaroxaban effectiveness & safety for the prevention of recurrence in patients with Deep Vein Thrombosis and Pulmonary Embolism
Scientific Title:Acronym J'xactly Study
Region
Japan

Condition
Condition Deep Vein Thrombosis and Pulmonary Embolism
Classification by specialty
Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness and safety of the direct factor Xa inhibitor rivaroxaban in domestic clinical use for patients with deep vein thrombosis and pulmonary embolism
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence/exacerbation of symptomatic venous thromboembolism (VTE)
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
・ Comparison of examples of treatment continuation/discontinuation or termination events
・ Serious adverse 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 with symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban for the purpose of treatment and prevention of recurrence of acute deep vein thrombosis and pulmonary embolism
Key exclusion criteria 1. Patients with a contraindication to rivaroxaban
2. Patients with chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis)
3. Patients with active bleeding
4. In addition, patients determined to be inappropriate for the study by the attending doctor
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Hirayama
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 hirayama.atsushi@nihon-u.ac.jp

Public contact
Name of contact person
1st name Serina
Middle name
Last name Nakamoto
Organization Mebix, Inc.
Division name Research Promotion Group
Zip code 107-0052
Address Akasaka Intercity,1-11-44 Akasaka, Minato-ku,Tokyo
TEL 0120-297-437
Homepage URL
Email jxactly@mebix.co.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd
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
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 日本大学医学部附属板橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 1039
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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 06 Day
Date of IRB
2016 Year 10 Month 21 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information There are currently three direct acting oral anticoagulants including rivaroxaban that can be used clinically against this disease, but rivaroxaban is most used worldwide and can be thought of as the standard drug. Rivaroxaban has been developed and trialed independently for both DVT and PE, and examination of the consistency of the separate development and trial data of DVT and PE in this study can be considered appropriate. For these reasons, and given that clinical evidence from XALIA in Europe has already been reported, rivaroxaban was used in the study.

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028814

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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