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

Takeshi Morimoto

Status and phase

Completed

Phase 4

Conditions

Neoplasms

Anticoagulant

Venous Thrombosis

Treatments

Drug: 12-month Edoxaban

Drug: 3-month Edoxaban

Study type

Interventional

Funder types

Other

Identifiers

NCT03895502

Y0019

Details and patient eligibility

About

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.

Full 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).

Enrollment

605 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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