Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients with Cancer Study

Phase 4

• Conditions: Deep vein thrombosis; Venous Thrombosis

• Registration Number: JPRN-jRCTs051190010
• Lead Sponsor: Yamashita Yugo

Brief Summary

In cancer patients with deep-vein thrombosis confined to the leg, 12 months of edoxaban treatment was better than 3 months of edoxaban treatment in recurrence of symptomatic venous thromboembolism and venous thromboembolism-related deaths. It was shown to be excellent as per the research hypothesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-24
• Study Completion: 2023-06-30
• Results First Posted: 2023-09-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 605

Inclusion Criteria

Patients with newly found isolated distal deep vein thrombosis complicated with active cancer who are scheduled to be treated by anticoagulation therapy.

Exclusion Criteria

1. Patients with anticoag ulation therapy for the Index event before 10 days of allocation.
2. Patient under anticoag ulation therapy for the purpose of other than the Index event.
3. Patients with thrombolysis therapy or IVC filter at the Index event.
4. Patients with creatinine clearance less than 30 ml/min.
5. Patients who are expected to have a life prognosis of 3 months or less.
6. Patients with pulmonary embolism.
7. Patients who are not appropriate for the participation of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic VTE recurrence event / VTE related death event at 12 months.

Secondary Outcome Measures

Name	Time	Method
Major bleeding event (ISTH criteria) at 12 months.