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

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ClinicalTrials.gov Identifier: NCT03091621
Recruitment Status : Unknown
Verified March 2017 by Atsushi Hirayama, Nihon University.
Recruitment status was:  Recruiting
First Posted : March 27, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Mebix Inc
Information provided by (Responsible Party):
Atsushi Hirayama, Nihon University

Brief 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

Condition or disease
Deep Vein Thrombosis 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]

  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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism
Actual Study Start Date : December 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. Acute coronary syndrome [ Time Frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months) ]
  8. Cerebral infarction [ Time Frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months) ]
  9. VTE related death [ Time Frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months) ]
  10. Cardiovascular death [ Time Frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months) ]
  11. All deaths [ Time Frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months) ]
  12. 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) ]
  13. 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) ]
  14. Serious adverse events [ Time Frame: From the time of research participation to 30th November 2019 (At least 1 year and 6 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091621


Locations
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Japan
Nihon University School of Medicine Recruiting
Tokyo, Itabashi-ku, Japan, 1738610
Contact: Atsushi Hirayama, professor    03-3972-8111      
Sponsors and Collaborators
Nihon University
Mebix Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Atsushi Hirayama, Principal Investigator, Nihon University School of Medicine Division of Cardiology, Department of Internal Medicine, Nihon University
ClinicalTrials.gov Identifier: NCT03091621    
Other Study ID Numbers: J'xactly
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by Atsushi Hirayama, Nihon University:
Deep Vein Thrombosis
pulmonary embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Venous Thrombosis
Recurrence
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants