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Completed

NCT Number: NCT07699796

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

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.

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Key information

Conditions

Venous Thrombosis Deep (Limbs) Cardiovascular Diseases Embolism and Thrombosis Thrombosis Varicose Veins Leg Vascular Diseases Venous Insufficiency Venous Insufficiency (Chronic)(Peripheral) Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Heart Artery and Vein Center of Fresno

Fresno, California, 93722, United States

About this study

The unit of randomization was the treated limb, assigned by a computer-generated random sequence. Some participants underwent bilateral procedures and could contribute limbs to different arms; within-participant correlation was addressed with patient-clustered robust standard errors and a one-limb-per-patient sensitivity analysis. The primary endpoint was clinically significant (AVF class ≥II) EHIT on the first post-ablation duplex, which was performed and interpreted by two registered vascular technologists blinded to treatment allocation, with adjudication by the treating physician.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older Undergoing great saphenous vein endovenous laser ablation for symptomatic reflux Concurrent below-knee foam sclerotherapy

Exclusion criteria

Known thrombophilia Current oestrogen or hormone-replacement therapy Family history of venous thromboembolism or thrombophilia Active malignancy Prior ipsilateral ablation Deep venous reflux or obstruction

Treatment and study plan

Apixaban

Drug

5 mg orally twice daily for 5 days

Other names: ELIQUIS

Rivaroxaban

Drug

20 mg orally once daily for 5 days

Other names: XARELTO

Primary outcomes

  1. Number of Limbs With Clinically Significant EHIT (AVF Class ≥II)

    Time frame: Up to 1 week after the ablation procedure

    Incidence of clinically significant EHIT (AVF class ≥II)

Secondary outcomes

  1. Number of Limbs With Any EHIT (AVF Class I-IV)

    Time frame: Up to 1 week after the ablation procedure

    Any EHIT (AVF class I-IV) - first post-ablation duplex

  2. Number of Limbs With Remote (Non-contiguous) Deep Vein Thrombosis

    Time frame: Up to 1 week after the ablation procedure

    Remote (non-contiguous) deep vein thrombosis

  3. Number of Limbs With Treated Great Saphenous Vein Closure

    Time frame: Up to 3 years after the ablation procedure

    Treated great saphenous vein closure

  4. Number of Limbs With Bleeding (ISTH Major, CRNM, or Minor)

    Time frame: Up to 30 days after the ablation procedure

    Bleeding (ISTH major / clinically relevant non-major / minor)

Sponsors and collaborators

Lead sponsor

Heart, Artery, and Vein Center of Fresno

Other

Registry information

Official study title

Randomized Trial of Rivaroxaban (Xarelto) and Apixaban (Eliquis) for the Prevention of Endothermal Heat-Induced Thrombosis (EHIT) and Deep Vein Thrombosis After Great Saphenous Vein Endovenous Laser Ablation

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 13, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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