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NCT Number: NCT07208695

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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 INR 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 informed consent.

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 platelet 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 (Child-Pugh class C), renal insufficiency (eGFR <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 informed consent form.

Treatment and study plan

Antiplatelet or Anticoagulant Drugs

Drug

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

Primary outcomes

  1. 6-month postoperative venous closure rate

    Time frame: 6 month

  2. 6-month postoperative venous closure rate

    Time frame: 6-month

Study contacts

Contact information is provided by the study sponsor or research team.

Chunshui He, Doctor

CONTACT

[email protected]

18981885601

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

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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