UMIN-CTR Clinical Trial

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

Deep Vein Thrombosis and Pulmonary Embolism

Classification by specialty

Cardiology	Vascular surgery	Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nihon University School of Medicine

Institute

Department

Personal name

Organization

Bayer Yakuhin, Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本大学医学部附属板橋病院（東京都）

Date of disclosure of the study information

2016

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Main results already published

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 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.

Registered date

2016

Year

11

Month

30

Day

Last modified on

2020

Year

09

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028814