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

Nihon University

Status: Unknown

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03091621

J'xactly

Details and patient eligibility

About

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

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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