Deep Vein ThrombosisNCT03091621
Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism
An observational study of Deep Vein Thrombosis and Pulmonary Embolism, run by Nihon University at 1 site in Japan.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2016to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 1. Symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban
Who cannot join
- Contraindication to rivaroxaban
- Chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis)
- Active bleeding
- Patients determined to be inappropriate for the study by the attending doctor
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Nihon University School of Medicine
Tokyo, Itabashi-ku, 1738610
Atsushi Hirayama, professor, 03-3972-8111
About this study
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
Read the detailed description
Research design: multicenter collaboration, prospective, non-interventional, observational research
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]
- Registration date
- Facility name
- Case registration number
- Patient identification code (appropriate number within the facility)
- Gender
- Birthdate
- Rivaroxaban commencement date
- Age at first prescription (automatic calculation display)
- Date of obtaining written consent
- Other
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- Deep Vein Thrombosis, pulmonary embolism
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence/exacerbation of symptomatic venous thromboembolism (VTE)
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary outcomes (14)
Onset/exacerbation of symptomatic pulmonary embolism (PE)
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Onset/exacerbation of symptomatic deep vein thrombosis (DVT)
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Major bleeding event (ISTH bleeding criteria)
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Non-major bleeding event (bleeding events that do not correspond to major bleeding)
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Recurrence/exacerbation of symptomatic venous thromboembolism during the initial strengthening treatment period
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Bleeding event during the initial strengthening treatment period
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Acute coronary syndrome
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Cerebral infarction
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
VTE related death
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Cardiovascular death
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
All deaths
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Relationship between change in D-dimer and recurrence
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Comparison of examples of treatment continuation/discontinuation events
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Serious adverse events
Measured: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startDec 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Collaborators
- Mebix Inc
- Responsible party
- Principal investigator, Atsushi Hirayama, Nihon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091621
- Sponsor's protocol ID
- J'xactly
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29934383
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03091621
- Acronym / sponsor ID
- J'xactly
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- Deep Vein Thrombosis, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Collaborators
- Mebix Inc
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Research design: multicenter collaboration, prospective, non-interventional, observational research
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]
- Registration date
- Facility name
- Case registration number
- Patient identification code (appropriate number within the facility)
- Gender
- Birthdate
- Rivaroxaban commencement date
- Age at first prescription (automatic calculation display)
- Date of obtaining written consent
- Other
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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 inclusion criteria (1 listed)
- 1. Symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban
Key exclusion criteria (4 listed)
- Contraindication to rivaroxaban
- Chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis)
- Active bleeding
- Patients determined to be inappropriate for the study by the attending doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence/exacerbation of symptomatic venous thromboembolism (VTE)
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
14 secondary outcomes
Onset/exacerbation of symptomatic pulmonary embolism (PE)
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Onset/exacerbation of symptomatic deep vein thrombosis (DVT)
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Major bleeding event (ISTH bleeding criteria)
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Non-major bleeding event (bleeding events that do not correspond to major bleeding)
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Recurrence/exacerbation of symptomatic venous thromboembolism during the initial strengthening treatment period
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Bleeding event during the initial strengthening treatment period
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Acute coronary syndrome
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Cerebral infarction
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
VTE related death
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Cardiovascular death
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
All deaths
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Relationship between change in D-dimer and recurrence
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Comparison of examples of treatment continuation/discontinuation events
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Serious adverse events
Time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 29934383Okumura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis and Pulmonary Embolism, run by Nihon University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence/exacerbation of symptomatic venous thromboembolism (VTE) (time frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.