Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

• Status: Recruiting
• Trial end date: 2023-09-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• All outpatients with first, acute (within 2 weeks), symptomatic, objectively confirmed distal DVT

• Compliance to the scheduled follow up plan

Exclusion Criteria:

• Age < 18 years or > 90 years

• Any absolute contraindication to anticoagulant treatment

• Pregnancy or breast-feeding

• 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 anticoagulant treatment

• Inability or refusal to provide informed consent

• Enrolled in another clinical trial simultaneously