UnknownPhase 3

Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

China480 participantsStarted 2021-08-01

Plain-language summary

The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute IDDVT. However, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. Thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic IDDVT of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18-90 * Outpatients with a first, acute (within 2 weeks), symptomatic, objectively confirmed isolated distal DVT * Compliance to the scheduled follow up plan * Ability and willing to participate and sign the informed consent. Exclusion Criteria: * Any absolute contraindication to anticoagulant treatment * Pregnancy or breast-feeding * Systolic pressure \> 180 mmHg or diastolic pressure \> 100 mmHg * Platelet count \< 100 × 10⁹ /L * Serum creatinine \> 180 mmol/L or creatinine clearance ≤30 ml/min * Liver disease associated with coagulopathy and high risk of bleeding * Clinically suspected or confirmed pulmonary embolism * Ipsilateral or contralateral proximal DVT * Any indication for long-term anticoagulation * Enrolled in another clinical trial simultaneously * Life expectancy \< 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographically confirmed recurrent venous thromboembolism

Timeframe: 6 months

Major or clinically relevant non-major bleeding events

Timeframe: 3 months

Trial details

NCT IDNCT04967573

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Contact for this trial

Weiguo Fu, PhD

17612117633 fu.weiguo@zs-hospital.sh.cn

View on ClinicalTrials.gov More Venous Thrombosis trials