NCT03895502

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: Takeshi Morimoto · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the optimal duration of anticoagulation therapy (3 months versus 12 months) with direct oral anticoagulant (edoxaban) for isolated distal deep vein thrombosis.

Detailed description

Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating PE and/or proximal DVT, although data on isolated distal DVT (IDDVT) has been quite limited. However, IDDVT was reported to account for about half of all the diagnoses of DVT detected on ultrasound in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines suggest the same approach for IDDVT patients with cancer as proximal DVT patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that IDDVT patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, we will randomly assign IDDVT patients with active cancer to receive either edoxaban for 3 months (short DOAC group) or edoxaban for 12 months (long DOAC group).

Conditions

• Venous Thrombosis
• Neoplasms
• Anticoagulant

Interventions

Type	Name	Description
DRUG	12-month Edoxaban	Prescription of Edoxaban for 12 months
DRUG	3-month Edoxaban	Prescription of Edoxaban for 3 months

Timeline

• Start date: 2019-05-27
• Primary completion: 2023-06-30
• Completion: 2023-08-31
• First posted: 2019-03-29
• Last updated: 2023-10-04

Locations

1 site across 1 country: Japan