Clinical trial

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

Name
Y0019
Description
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.
Trial arms
Trial start
2019-05-27
Estimated PCD
2023-06-30
Trial end
2023-08-31
Status
Completed
Phase
Early phase I
Treatment
12-month Edoxaban
Prescription of Edoxaban for 12 months
Arms:
12-month Edoxaban
3-month Edoxaban
Prescription of Edoxaban for 3 months
Arms:
3-month Edoxaban
Size
605
Primary endpoint
Symptomatic VTE recurrence event or VTE related death event
12 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 605, 'type': 'ACTUAL'}}
Updated at
2023-10-04

1 organization

1 product

3 indications

Organization
Takeshi Morimoto
Product
Edoxaban
Indication
Cancer
Indication
Anticoagulant