Venous Thrombosis Deep (Limbs)Phase 4NCT07699796
Apixaban vs Rivaroxaban vs No Anticoagulant to Prevent EHIT After Great Saphenous Vein Laser Ablation
A Phase 4 study testing Apixaban and Rivaroxaban in people with Venous Thrombosis Deep (Limbs) and Venous Insufficiency (Chronic)(Peripheral), run by Heart, Artery, and Vein Center of Fresno at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis Deep (Limbs), Venous Insufficiency (Chronic)(Peripheral), Varicose Veins Leg
- What is being tested?
- Apixaban and Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 15 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older Undergoing great saphenous vein endovenous laser ablation for symptomatic reflux Concurrent below-knee foam sclerotherapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Heart Artery and Vein Center of Fresno
Fresno, California, 93722
About this study
Official 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
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.
Read the 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.
- Conditions
- Venous Thrombosis Deep (Limbs), Venous Insufficiency (Chronic)(Peripheral), Varicose Veins Leg, Venous Thrombosis
- Being tested
- Apixaban, Rivaroxaban
- Keywords
- EHIT, Endothermal heat-induced thrombosis, Endovenous laser ablation, Great saphenous vein, Apixaban, Rivaroxaban, Thromboprophylaxis
- Medical subject headings
- Venous Thrombosis, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called ELIQUIS
5 mg orally twice daily for 5 days
RivaroxabanDrug
Also called XARELTO
20 mg orally once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| apixaban | Experimental | Experimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure Receives: Drug: Apixaban |
| rivaroxaban | Experimental | Experimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure Receives: Drug: Rivaroxaban |
| No anticoagulant | No intervention | "No anticoagulant" · No Intervention · no post-procedural anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Limbs With Clinically Significant EHIT (AVF Class ≥II)
Incidence of clinically significant EHIT (AVF class ≥II)
Measured: Up to 1 week after the ablation procedure
Secondary outcomes (4)
Number of Limbs With Any EHIT (AVF Class I-IV)
Any EHIT (AVF class I-IV) - first post-ablation duplex
Measured: Up to 1 week after the ablation procedure
Number of Limbs With Remote (Non-contiguous) Deep Vein Thrombosis
Remote (non-contiguous) deep vein thrombosis
Measured: Up to 1 week after the ablation procedure
Number of Limbs With Treated Great Saphenous Vein Closure
Treated great saphenous vein closure
Measured: Up to 3 years after the ablation procedure
Number of Limbs With Bleeding (ISTH Major, CRNM, or Minor)
Bleeding (ISTH major / clinically relevant non-major / minor)
Measured: Up to 30 days after the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start6 Mar 2018
- Primary completion4 Nov 2020
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Thrombosis Deep (Limbs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart, Artery, and Vein Center of Fresno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sanjay srivatsa, Heart, Artery, and Vein Center of Fresno
- Investigators
- Sanjay S Srivatsa, MD, Principal investigator, Heart, Artery, and Vein Center of Fresno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699796
- Sponsor's protocol ID
- SAMC-18001
- Other IDs
- 18001 - Type: Other;
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36592692
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07699796
- Acronym / sponsor ID
- SAMC-18001
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Heart, Artery, and Vein Center of FresnoUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| apixaban | Experimental | Drug: ApixabanExperimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure |
| rivaroxaban | Experimental | Drug: RivaroxabanExperimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure |
| No anticoagulant | No intervention | –"No anticoagulant" · No Intervention · no post-procedural anticoagulant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or older Undergoing great saphenous vein endovenous laser ablation for symptomatic reflux Concurrent below-knee foam sclerotherapy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: ELIQUIS5 mg orally twice daily for 5 days | Drug | apixaban |
| RivaroxabanAlso: XARELTO20 mg orally once daily for 5 days | Drug | rivaroxaban |
Primary outcome
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)
4 secondary outcomes
Number of Limbs With Any EHIT (AVF Class I-IV)
Time frame: 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
Number of Limbs With Treated Great Saphenous Vein Closure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 36592692Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay S Srivatsa, MD principal investigator
Heart, Artery, and Vein Center of Fresno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban and Rivaroxaban in people with Venous Thrombosis Deep (Limbs) and Venous Insufficiency (Chronic)(Peripheral), run by Heart, Artery, and Vein Center of Fresno at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Limbs With Clinically Significant EHIT (AVF Class ≥II) (time frame: Up to 1 week after the ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07699796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.