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

JRCT ID: jRCTs051190010

Registered date:24/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Deep vein thrombosis
• Date of first enrollment: 24/05/2019
• Target sample size: 600
• Study type: Interventional
• Intervention(s): Three months of Edoxaban treatment g roup (Short DOAC group) and 12 months of Edoxaban treatment group (Long DOAC group)

Outcome(s)

• Primary Outcome: Symptomatic VTE recurrence event / VTE related death event at 12 months.
• Secondary Outcome: Major bleeding event (ISTH criteria) at 12 months.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with newly found isolated distal deep vein thrombosis complicated with active cancer who are scheduled to be treated by anticoagulation therapy.

Exclude 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.

Related Information

• Primary Sponsor: Yamashita Yugo
• Source(s) of Monetary Support: Daiichi sankyo
• Secondary ID(s): NCT03895502