Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03091621
• Other study ID #: J'xactly
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 27, 2017
• Start date: December 2016
• Est. completion date: November 2019

Study information

• Verified date: March 2017
• Source: Nihon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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]

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban

Exclusion Criteria:

1. Contraindication to rivaroxaban

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Recurrence
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Japan	Nihon University School of Medicine	Tokyo	Itabashi-ku

Sponsors (2)

Lead Sponsor	Collaborator
Nihon University	Mebix Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence/exacerbation of symptomatic venous thromboembolism (VTE)		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Onset/exacerbation of symptomatic pulmonary embolism (PE)		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Onset/exacerbation of symptomatic deep vein thrombosis (DVT)		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Major bleeding event (ISTH bleeding criteria)		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Non-major bleeding event (bleeding events that do not correspond to major bleeding)		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Recurrence/exacerbation of symptomatic venous thromboembolism during the initial strengthening treatment period		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Bleeding event during the initial strengthening treatment period		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Acute coronary syndrome		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Cerebral infarction		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	VTE related death		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Cardiovascular death		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	All deaths		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Relationship between change in D-dimer and recurrence		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Comparison of examples of treatment continuation/discontinuation events		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)
Secondary	Serious adverse events		From the time of research participation to 30th November 2019 (At least 1 year and 6 months)