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Not yet recruitingNCT07208695Updated Oct 6, 2025

Effect of Oral Antiplatelet or Anticoagulant Drugs on Postoperative Bleeding Risk and Venous Closure Rate in Patients With Lower Extremity Varicose Veins After Radiofrequency Ablation

An observational study in Oral Antiplatele, Anticoagulant Drugs and Lower Extremity Varicose Veins, sponsored by Chengdu University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by Chengdu University of Traditional Chinese Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study summary

This observational study aims to assess the effect of oral antiplatelet or anticoagulant drugs on key postoperative outcomes in patients with lower extremity varicose veins who have undergone radiofrequency ablation. Its main objectives are to determine the impact of these medications on postoperative 30-day bleeding risk and postoperative 3-month venous closure rate in this patient population. Researchers will compare three groups-patients receiving oral antiplatelet drugs, those receiving oral anticoagulant drugs, and those not receiving either type of drug-to identify differences in the two key outcomes. Participants will complete baseline data collection (including medical history, medication use, and lower extremity venous assessment) before or shortly after radiofrequency ablation, undergo 30-day postoperative follow-up to evaluate bleeding events (such as minor bleeding or major bleeding requiring medical intervention), receive venous ultrasound at 3 months postoperatively to measure venous closure rate, and report any medication changes or adverse events during the follow-up period.

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Conditions studied

  • Oral Antiplatele
  • Anticoagulant Drugs
  • Lower Extremity Varicose Veins
  • Radiofrequency Ablation

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03

In context

Varicose Veins

226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.

This study's planned enrollment of 40 is below the median of 159 across 62 observational studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

Chengdu University of Traditional Chinese Medicine is the lead sponsor of 59 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population includes adults aged ≥18 years with confirmed primary lower extremity varicose veins (CEAP classification C2-C6), validated by clinical examination and duplex ultrasound, who have undergone endovenous radiofrequency ablation (RFA) of the great saphenous vein as the primary treatment. Participants are stratified into three groups based on postoperative antithrombotic medication use per routine clinical practice: those taking standard-dose oral antiplatelet drugs, those using standard oral anticoagulants, and a control group without antithrombotic agents. Excluded individuals are patients with secondary varicose veins (e.g., due to deep vein thrombosis or venous malformations), coagulation disorders, postoperative non-oral antithrombotic use, major bleeding within 3 months before RFA, severe hepatic/renal insufficiency, life-threatening systemic diseases, or those unable to complete follow-up or provide informed consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or older, with a confirmed diagnosis of primary lower extremity varicose veins (CEAP classification C2-C6) based on clinical examination and duplex ultrasound.
  • Underwent endovenous radiofrequency ablation (RFA) of the great saphenous vein as the primary intervention.
  • Postoperatively, either: (a) continuously uses standard-dose oral antiplatelet drugs (e.g., aspirin 100mg/day, clopidogrel 75mg/day) or oral anticoagulant drugs (e.g., warfarin with maintained at 2.0-3.0, direct oral anticoagulants at standard therapeutic doses) as per clinical routine, or (b) does not use any antithrombotic drugs.
  • Able to understand and comply with the follow-up schedule (including 30-day bleeding assessment and 6-month duplex ultrasound examination) and provide .

Exclusion criteria

Exclusion Criteria:

  • Presence of secondary varicose veins caused by deep vein thrombosis, venous malformation, or other vascular disorders.
  • History of coagulation disorders (e.g., hemophilia, thrombocytopenia with count \<100×10⁹/L) or use of other antithrombotic agents (e.g., low-molecular-weight heparin, glycoprotein IIb/IIIa inhibitors) postoperatively.
  • Major bleeding events (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 3 months prior to RFA.
  • Severe hepatic insufficiency ( class C), renal insufficiency ( \<30 mL/min/1.73m²), or other life-threatening systemic diseases.
  • Unable to complete follow-up due to mental disorders, mobility limitations, or other reasons, or refusal to sign the form.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • DrugAntiplatelet or Anticoagulant Drugs

    The goal of this observational study is to assess the effect of postoperative continuous use of standard-dose oral antiplatelet (e.g., aspirin, clopidogrel) or anticoagulant drugs (e.g., warfarin, direct oral anticoagulants) on key postoperative outcomes in patients with primary lower extremity varicose veins who have undergone endovenous radiofrequency ablation (RFA) of the great saphenous vein. Unlike studies focusing on preoperative medication adjustment or single-drug cohorts, this study specifically targets routine postoperative medication use without protocol-mandated dose changes, and distinguishes between two major classes of antithrombotic agents while including a non-user control group. The main questions it aims to answer are: 1) Whether postoperative oral antiplatelet/anticoagulant use correlates with increased 30-day bleeding risk (defined by standardized criteria: minor = localized ecchymosis needing no intervention; major = bleeding requiring transfusion or surgical hemo

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What researchers measure

Primary outcomes

  1. 6-month postoperative venous closure rate

    Time frame: 6 month

  2. 6-month postoperative venous closure rate

    Time frame: 6-month

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • San Norberto Garcia EM, Merino B, Taylor JH, Vizcaino I, Vaquero C. Low-molecular-weight heparin for prevention of venous thromboembolism after varicose vein surgery in moderate-risk patients: a randomized, controlled trial. Ann Vasc Surg. 2013 Oct;27(7):940-6. doi: 10.1016/j.avsg.2013.03.006. PubMed 23993109 ↗
  • Gonzalez Ochoa AJ, Carrillo J, Manriquez D, Manrique F, Vazquez AN. Reducing hyperpigmentation after sclerotherapy: A randomized clinical trial. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):154-162. doi: 10.1016/j.jvsv.2020.06.019. Epub 2020 Jul 30. PubMed 32739509 ↗
  • Beyer-Westendorf J, Schellong SM, Gerlach H, Rabe E, Weitz JI, Jersemann K, Sahin K, Bauersachs R; SURPRISE investigators. Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial. Lancet Haematol. 2017 Mar;4(3):e105-e113. doi: 10.1016/S2352-3026(17)30014-5. Epub 2017 Feb 16. PubMed 28219692 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07208695
Lead sponsor
Chengdu University of Traditional Chinese Medicine
Responsible party
Chunshui He (chief physician, Chengdu University of Traditional Chinese Medicine) — Principal investigator
First posted
Oct 6, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Apr 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Oct 6, 2025

Study contacts

Chunshui He, Doctor
Contact
Chunshuihe@msn.com
18981885601

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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