Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

Phase 3

• Conditions: Deep Vein Thrombosis
• Interventions: Drug: Placebo; Drug: rivaroxaban

• Registration Number: NCT02722447
• Lead Sponsor: Walter Ageno

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-13
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Study Start: 2017-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-24
• Last Update Posted: 2018-11-27
• Primary Completion: 2019-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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)
Rivaroxaban	rivaroxaban	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)

Primary Outcome Measures

Name	Time	Method
Rate of recurrent venous thromboembolism	24 months	Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism

Secondary Outcome Measures

Name	Time	Method
Rate of cardiovascular events	24 months
Rate of major bleeding events	Until 2 days from the last intake of the study drug
Rate of clinically relevant non-major bleeding events	Until 2 days from the last intake of the study drug
Percentage of patients with residual vein occlusion	3 months and 24 months

Trial Locations

Locations (7)

Ospedale di Faenza; 🇮🇹 Faenza, Italy

Ospedale di Padova; 🇮🇹 Padua, Italy

Ospedale di Pieve di Soligo; 🇮🇹 Pieve di Soligo, Italy

Ospedale di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

University of Siena; 🇮🇹 Siena, Italy

Ospedale di Circolo; 🇮🇹 Varese, Italy

University Of Insubria; 🇮🇹 Varese, Italy