drugset / Trial / NCT07699796

Apixaban vs Rivaroxaban vs No Anticoagulant to Prevent EHIT After Great Saphenous Vein Laser Ablation

NCT07699796

Phase 4 Completed 564 enrolled Heart, Artery, and Vein Center of Fresno
RandomizedParallel-groupSingle-blindPrevention

Summary

Endothermal heat-induced thrombosis (EHIT) is a thrombotic complication specific to endovenous thermal ablation of the great saphenous vein (GSV), for which no prophylactic regimen is standardized. This single-centre, single-operator randomized trial compared a brief 5-day post-procedural course of the direct oral anticoagulants apixaban and rivaroxaban against no anticoagulation for the prevention of EHIT after GSV endovenous laser ablation performed with concurrent below-knee foam sclerotherapy. Treated limbs were randomly allocated 2:1:1 (no anticoagulant : rivaroxaban : apixaban), and EHIT was graded on post-ablation duplex by the American Venous Forum (AVF) classification.

Timeline

Start
2018-03-06
Primary completion
2020-11-04
Completion
2021-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule 5 mg Oral
Subject Rivaroxaban Other / unclassified 20 mg Oral