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

Takeshi Morimoto605 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

605

Conditions

Venous Thrombosis Neoplasms Anticoagulant

Interventions

12-month EdoxabanDRUG

Prescription of Edoxaban for 12 months

3-month EdoxabanDRUG

Prescription of Edoxaban for 3 months

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Kyoto, Japan

Outcomes

Primary Outcomes

Symptomatic VTE recurrence event or VTE related death event

Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. VTE related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer.)

Time frame: 12 months

Secondary Outcomes

Major bleeding event (ISTH criteria)

Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ.

Time frame: 12 months

All-cause death

Time frame: 12 months

Symptomatic VTE recurrence event

Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy.

Time frame: 12 months

VTE related death event

VTE related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer.)

Time frame: 12 months

Clinically relevant non-major (CRNM) bleeding

A bleeding event will be classified as a clinically relevant non-major bleeding event if it is overt (i.e. is symptomatic or visualized by examination) not meeting the criteria for major bleeding, requires medical attention or is associated with discomfort for the subject such as pain, or impairment of activities of daily life.

Data from ClinicalTrials.gov

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