Prospective study of non-vitamin K antagonist oral anticoagulants (NOACs) management in Japanese patients with deep vein thrombosis and pulmonary embolism (DVT/PE)

Prospective study of non-vitamin K antagonist oral anticoagulants (NOACs) management in Japanese patients with deep vein thrombosis and pulmonary embolism (DVT/PE) - Prospective study on management of DVT and PE with NOACs (KUROSIO study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023747

Enrollment

1000

Registered

2016-08-25

Start date

2016-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thrombosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese males and females who meet following criterion either (1) or (2), and begin treatment with NOACs or take already. (1) Persons with episode of acute symptomatic pulmonary thromboembolism that thromboemboli are detected in pulmonary arteries by imaging and that corresponding symptoms are confirmed, and persons with episode of acute proximal deep vein thrombosis that new thrombi are detected in proximal deep veins by imaging whether corresponding symptom is confirmed or not. (2) Persons with episode of acute isolated calf deep vein thrombosis that new thrombi are detected only in calf deep veins by imaging whether corresponding symptom is confirmed or not.

Exclusion criteria

Exclusion criteria: (1) Persons who are initiated or planed warfarin or other Vitamin K antagonists therapy (2) Persons who are initiated or planed non-drug therapy (3) Persons who are not applicable to participate in this study by investigators

Design outcomes

Primary

Measure	Time frame
Incidence of recurrence of symptomatic venous thromboembolism and hemorrhagic adverse events up to 52 weeks after diagnosis	—

Secondary

Measure	Time frame
1) Recurrence of symptomatic venous thromboembolism at 52, 104 and 156 weeks 2) Incidence of hemorrhagic adverse events at 52, 104 and 156 weeks 3) Patient background factors of venous thromboembolism 4) Effect and complication of treatment, and recurrence of symptomatic acute pulmonary thromboembolism 5) Effect and complication of treatment, and recurrence of proximal deep vein thrombosis 6) Effect and complication of treatment, and recurrence of isolated calf deep vein thrombosis 7) Adverse events other than bleeding event related to treatment of venous thromboembolism	—

Measure

Time frame

1) Recurrence of symptomatic venous thromboembolism at 52, 104 and 156 weeks 2) Incidence of hemorrhagic adverse events at 52, 104 and 156 weeks 3) Patient background factors of venous thromboembolism 4) Effect and complication of treatment, and recurrence of symptomatic acute pulmonary thromboembolism 5) Effect and complication of treatment, and recurrence of proximal deep vein thrombosis 6) Effect and complication of treatment, and recurrence of isolated calf deep vein thrombosis 7) Adverse events other than bleeding event related to treatment of venous thromboembolism

—

Countries

Japan

Contacts

Public ContactNorikazu Yamada

Kuwana City Medical Center Department of Cardiology

n-yamada@kuwanacmc.or.jp0594-22-1211

Outcome results