Apixaban vs Rivaroxaban vs No Anticoagulant to Prevent EHIT After Great Saphenous Vein Laser Ablation
NCT07699796 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 564
Last updated 2026-07-16
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.
Conditions
- Venous Thrombosis Deep (Limbs)
- Venous Insufficiency (Chronic)(Peripheral)
- Varicose Veins Leg
- Venous Thrombosis
Interventions
- DRUG
-
Apixaban
5 mg orally twice daily for 5 days
- DRUG
-
20 mg orally once daily for 5 days
Sponsors & Collaborators
-
Heart, Artery, and Vein Center of Fresno
lead OTHER
Principal Investigators
-
Sanjay S Srivatsa, MD · Heart, Artery, and Vein Center of Fresno
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-06
- Primary Completion
- 2020-11-04
- Completion
- 2021-06-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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