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

NCT03091621 | Unknown

• 1 other identifier: J'xactly
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Keywords

Deep Vein Thrombosis; pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Onset/exacerbation of symptomatic pulmonary embolism (PE)

  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)

  From the time of research participation to 30th November 2019 (At least 1 year and 6 months)

• Major bleeding event (ISTH bleeding criteria)

  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)

  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

  From the time of research participation to 30th November 2019 (At least 1 year and 6 months)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \. Symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban

You may not qualify if:

• 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

Sponsors & Collaborators

• Nihon University: lead
• Mebix Inc: collaborator

Study Sites (1)

Nihon University School of Medicine

Tokyo, Itabashi-ku, 1738610, Japan

RECRUITING

Related Publications (1)

• 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.

  PMID: 29934383 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Nihon University School of Medicine Division of Cardiology, Department of Internal Medicine

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: December 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

JP (1)