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

July 14, 2026 updated by: sanjay srivatsa, Heart, Artery, and Vein Center of Fresno

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

564

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93722
        • Heart Artery and Vein Center of Fresno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: apixaban
Experimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure
Drug: Apixaban
5 mg orally twice daily for 5 days
Other Names:
  • ELIQUIS
Experimental: rivaroxaban
Experimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure
Drug: Rivaroxaban
20 mg orally once daily for 5 days
Other Names:
  • XARELTO
No Intervention: No anticoagulant
"No anticoagulant" · No Intervention · no post-procedural anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 1 week after the ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 week after the ablation procedure
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
Up to 1 week after the ablation procedure
Number of Limbs With Treated Great Saphenous Vein Closure
Time Frame: Up to 3 years after the ablation procedure
Treated great saphenous vein closure
Up to 3 years after the ablation procedure
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)
Up to 30 days after the ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart, Artery, and Vein Center of Fresno

Investigators

  • Principal Investigator: Sanjay S Srivatsa, MD, Heart, Artery, and Vein Center of Fresno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2018

Primary Completion (Actual)

November 4, 2020

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAMC-18001
  • 18001 - Type: Other; (Other Identifier: Saint Agnes Medical Center IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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