Clinical trial NCT03895502: Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
Official title: Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thrombosis
Neoplasms
Anticoagulant
Keywords: Venous Thrombosis
Neoplasms
Anticoagulant
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 605
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Symptomatic VTE recurrence event or VTE related death event
timeFrame: 12 months
Secondary outcomes:
measure: Major bleeding event (ISTH criteria)
timeFrame: 12 months
measure: All-cause death
timeFrame: 12 months
measure: Symptomatic VTE recurrence event
timeFrame: 12 months
measure: VTE related death event
timeFrame: 12 months
measure: Clinically relevant non-major (CRNM) bleeding
timeFrame: 12 months
measure: Clinically relevant bleeding
timeFrame: 12 months
measure: Bleeding related death event
timeFrame: 12 months
measure: Unsuspected recurrent DVT by follow-up ultrasound examinations
timeFrame: 12 months
measure: Unsuspected recurrent VTE by any imaging examinations
timeFrame: 12 months
measure: Change of serum D-dimer levels during follow-up period
timeFrame: 12 months
measure: Any adverse outcomes during invasive procedures
timeFrame: 12 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Study officials:
affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD, PhD
role: STUDY_CHAIR
References: