Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism
NCT ID: NCT03091621
Last Updated: 2017-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1000 participants
OBSERVATIONAL
2016-12-31
2019-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
NCT01516814
Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
NCT01516840
Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban
NCT03214172
A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Database
NCT04923139
Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
NCT02558465
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Research outline:
Registration period: Dec 2016 (after ethics committee approval) to May 2018 (1 year and 6 months) Investigation period: Dec 2016 (after ethics committee approval) to Nov 2019 (At least 1 year and 6 months) Target number of participants: 1,000 participants Estimated number of participating institutions: 150 medical institutions Research secretariat: Mebix, Inc.
Research procedure:
* Perform patient registration within 3 weeks of first prescription
* Also record when the drug was discontinued for any reason, such as an event or bleeding etc, between the time of first prescription and registration
* Track progress as much as possible until the end of the study period, regardless of continuation or discontinuation of study drug administration, and also in cases where there is manifestation of efficacy or safety events
* Track progress of all cases as much as possible until the end of the study period, regardless of continuation, discontinuation or termination of study drug administration. Patients transferred to the hospital are managed in the same way.
Registration method:
Register case information in the WEB registration system (EDC) after obtaining written consent from the research participant him/herself or the legal guardian for all cases compliant with the registration criteria and not in conflict with the exclusion criteria. Administer rivaroxaban in compliance with the approved dosage in the separate attached document. Furthermore, when the usage or dose are adjusted at the discretion of the research doctor, record the dose adjustment and reason. EDC will be used for case data entry.
\[EDC; Items to be entered into the case registration screen\]
1. Registration date
2. Facility name
3. Case registration number
4. Patient identification code (appropriate number within the facility)
5. Gender
6. Birthdate
7. Rivaroxaban commencement date
8. Age at first prescription (automatic calculation display)
9. Date of obtaining written consent
10. Other
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis)
3. Active bleeding
4. Patients determined to be inappropriate for the study by the attending doctor
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mebix Inc
INDUSTRY
Nihon University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Atsushi Hirayama
Principal Investigator, Nihon University School of Medicine Division of Cardiology, Department of Internal Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nihon University School of Medicine
Tokyo, Itabashi-ku, Japan
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Atsushi Hirayama, professor
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Okumura Y, Fukuda I, Nakamura M, Yamada N, Takayama M, Maeda H, Yamashita T, Ikeda T, Mo M, Yamazaki T, Hirayama A; J'xactly Investigators. Design and rationale for the Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients with Deep Vein Thrombosis and Pulmonary Embolism (J'xactly) study. BMJ Open. 2018 Jun 22;8(6):e020286. doi: 10.1136/bmjopen-2017-020286.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
J'xactly
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.