Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Venous Thrombosis

Treatments: Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT04967573

B2021-175R

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 2 patient groups

Prophylactic Anticoagulation

Experimental group

Description:

Rivaroxaban 10 mg od for 3 months

Treatment:

Drug: Rivaroxaban

Therapeutic Anticoagulation

Active Comparator group

Description:

Rivaroxaban 20 mg od for 3 months

Treatment:

Drug: Rivaroxaban