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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2022
  • participants needed
    600
  • sponsor
    Takeshi Morimoto
Updated on 26 January 2021
thrombosis
clot
cancer
anticoagulants
primary cancer
deep vein thrombosis
edoxaban
venous thrombosis
deep venous thrombosis of lower extremity

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.

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).

Details
Condition Venous Thrombosis, Cancer, Anticoagulants, Thromboembolism, Thrombosis, Blood Clots, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neoplasms, Deep Vein Thrombosis, anticoagulant, blood thinner, agents, anticoagulant, anticoagulation agents, blood thinners, anticoagulant drugs, anti-coagulant
Treatment 12-month Edoxaban, 3-month Edoxaban
Clinical Study IdentifierNCT03895502
SponsorTakeshi Morimoto
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 20 yrs?
Gender: Male or Female
Do you have any of these conditions: Cancer (Pediatric) or Venous Thrombosis or Blood Clots or Thromboembolism or Cancer/Tumors or Anticoagulants or Deep Vein Thrombosis or Cancer or Ewin...?
Do you have any of these conditions: Cancer or Ewing's Family Tumors or anti-coagulant or anticoagulant drugs or Cancer/Tumors or agents, anticoagulant or Blood Clots or Thromboembolism o...?
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
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