Oral AntiplateleNCT07208695
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 of Oral Antiplatele and Anticoagulant Drugs, run by Chengdu University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Antiplatele, Anticoagulant Drugs, Lower Extremity Varicose Veins
- What is being tested?
- Antiplatelet or Anticoagulant Drugs
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Oral Antiplatele, Anticoagulant Drugs, Lower Extremity Varicose Veins, Radiofrequency Ablation
- Being tested
- Antiplatelet or Anticoagulant Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet or Anticoagulant DrugsDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month postoperative venous closure rate
Measured: 6 month
6-month postoperative venous closure rate
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral AntiplateleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208695
- Sponsor's protocol ID
- ChengduUTCM 276
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23993109Gonzalez 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 32739509Beyer-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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07208695
- Acronym / sponsor ID
- ChengduUTCM 276
- Conditions
- Oral Antiplatele, Anticoagulant Drugs, Lower Extremity Varicose Veins, Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Antiplatelet or Anticoagulant DrugsThe 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 | Drug | – |
Primary outcome
6-month postoperative venous closure rate
Time frame: 6 month
6-month postoperative venous closure rate
Time frame: 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 23993109San 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.
- Background: PubMed 32739509Gonzalez 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.
- Results publication: PubMed 28219692Beyer-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.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Antiplatele and Anticoagulant Drugs, run by Chengdu University of Traditional Chinese Medicine.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunshui He, Doctor (18981885601, Chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month postoperative venous closure rate (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT07208695, which also lists 3 linked publications.
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 6 Oct 2025.