Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis (RIDTS)

Walter Ageno

Status and phase: Unknown; Phase 3

Conditions: Deep Vein Thrombosis

Treatments: Drug: Placebo; Drug: rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02722447

2016-000958-36

Details and patient eligibility

About

The treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this study is to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Objective diagnosis of isolate distal deep vein thrombosis within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of low molecular weight heparin: 6 doses; of fondaparinux: 3 doses).

Exclusion criteria

• Age < 18 years
• Any absolute contraindication to anticoagulant treatment
• Pregnancy or breast-feeding
• Presence of active cancer
• Concomitant presence of proximal deep vein thrombosis or pulmonary embolism
• Any concomitant indication for long-term anticoagulant treatment
• Creatinine clearance ≤30 ml/min, according to Cockcroft-Gault equation
• Cirrhosis Child-Pugh score B or C
• Liver disease associated with coagulopathy and high risk of bleeding
• Any other contraindication to rivaroxaban as per local SmPC
• Failure to provide written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,100 participants in 2 patient groups

Rivaroxaban

Active Comparator group

Description:

Rivaroxaban 20 mg od for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks and 20 mg od for 3 weeks)

Treatment:

Drug: rivaroxaban

Placebo

Experimental group

Description:

Placebo for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks followed by 20 mg od for 3 weeks)

Treatment:

Drug: Placebo