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

NCT07699796 | Completed Phase 4 FDA Drug

• 2 other identifiers: SAMC-1800118001 - Type: Other;
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EHIT; Endothermal heat-induced thrombosis; Endovenous laser ablation; Great saphenous vein; Apixaban; Rivaroxaban; Thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

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

  Incidence of clinically significant EHIT (AVF class ≥II)

  Up to 1 week after the ablation procedure

Secondary Outcomes (4)

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

  Up to 1 week after the ablation procedure

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

  Up to 1 week after the ablation procedure

• Number of Limbs With Treated Great Saphenous Vein Closure

  Up to 3 years after the ablation procedure

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

  Up to 30 days after the ablation procedure

Study Arms (3)

apixaban

EXPERIMENTAL

Experimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure

Drug: Apixaban

rivaroxaban

EXPERIMENTAL

Experimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure

Drug: Rivaroxaban

No anticoagulant

NO INTERVENTION

"No anticoagulant" · No Intervention · no post-procedural anticoagulant

Interventions

Apixaban DRUG

5 mg orally twice daily for 5 days

Also known as: ELIQUIS

apixaban

Rivaroxaban DRUG

20 mg orally once daily for 5 days

Also known as: XARELTO

rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart, Artery, and Vein Center of Fresno: lead

Study Sites (1)

Heart Artery and Vein Center of Fresno

Fresno, California, 93722, United States

Location

Related Publications (1)

• Yang J, Chung S, Srivatsa S. Prospective randomized trial of antithrombotic strategies following great saphenous vein ablation using injectable polidocanol endovenous microfoam (Varithena). J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):488-497.e4. doi: 10.1016/j.jvsv.2022.12.008. Epub 2022 Dec 31.

  PMID: 36592692 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Venous Insufficiency

Interventions

apixaban; Rivaroxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sanjay S Srivatsa, MD

  Heart, Artery, and Vein Center of Fresno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Who is masked: Outcomes Assessor (duplex read by blinded technologists)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Title: Principal Investigator · Affiliation: Heart Artery and Vein Center of Fresno

Model Details: Parallel Assignment · Number of Arms: 3 Allocation: Randomized Masking: Single → Who is masked: Outcomes Assessor (duplex read by blinded technologists) 564 - Actual participants (723 treated limbsanalyzed units)

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 13, 2026
• Study Start: March 6, 2018
• Primary Completion: November 4, 2020
• Study Completion: June 15, 2021
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)