drugset / Trial / NCT04967573

Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

NCT04967573

Phase 3 Unknown 480 enrolled Shanghai Zhongshan Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute IDDVT. However, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. Thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic IDDVT of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.

Timeline

Start
2021-08-01
Primary completion
2023-06-30
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 10 mg
Subject Rivaroxaban Other / unclassified 20 mg