Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

Phase 3

• Conditions: Venous Thrombosis
• Interventions: Drug: Rivaroxaban

• Registration Number: NCT04967573
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-19
• Study Start: 2021-08-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-16
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic Anticoagulation	Rivaroxaban	Rivaroxaban 10 mg od for 3 months
Therapeutic Anticoagulation	Rivaroxaban	Rivaroxaban 20 mg od for 3 months

Primary Outcome Measures

Name	Time	Method
Radiographically confirmed recurrent venous thromboembolism	6 months	Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.
Major or clinically relevant non-major bleeding events	3 months	Major bleeding events are defined according to the International Society on Thrombosis and Haemostasis criteria. Clinically relevant non-major bleeding events refer to which do not meet the mentioned criteria of major bleeding but need at least an unscheduled in-person consultant.

Secondary Outcome Measures

Name	Time	Method
Individual component of primary outcomes (e.g. proximal extension, major bleeding)	6 months	Individual component of primary outcomes, including proximal extension of isolated distal DVT, new contralateral proximal DVT, new pulmonary embolism, major bleeding events, clinically relevant non-major bleeding events.
All-cause death	6 months
Residual vein occlusion	6 months
Post-thrombotic syndrome	6 months

Trial Locations

Locations (4)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China

Huadong Hospital affiliated to Fudan University; 🇨🇳 Shanghai, China

Shanghai General Hospital; 🇨🇳 Shanghai, China

Shanghai Wusong Hospital; 🇨🇳 Shanghai, China