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

No results posted yet for this study

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

Rivaroxaban

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699796 on ClinicalTrials.gov