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

Conditions

• Varicose Veins Leg
• Venous Insufficiency (Chronic)(Peripheral)
• Venous Thrombosis
• Venous Thrombosis Deep (Limbs)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apixaban — DRUG
  5 mg orally twice daily for 5 days
• Rivaroxaban — DRUG
  20 mg orally once daily for 5 days

Study Details

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.

Key Dates

First listed

Jul 13, 2026

Start date

Mar 6, 2018

Status verified

Jul 2026

Primary completion

Nov 4, 2020

Completion

Jun 15, 2021

Study Design

Enrollment

564 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: apixaban
  Experimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure
• Experimental: rivaroxaban
  Experimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure
• No Intervention: No anticoagulant
  "No anticoagulant" · No Intervention · no post-procedural anticoagulant

Primary Outcome Measure

Number of Limbs With Clinically Significant EHIT (AVF Class ≥II) [ Time Frame: Up to 1 week after the ablation procedure ]

Locations (1)

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