Treatment of Splanchnic Vein Thrombosis With Rivaroxaban. A Pilot, Prospective Cohort Study

Phase 3

• Conditions: Portal Vein Thrombosis; Mesenteric Vein Thrombosis; Splenic Vein Thrombosis
• Interventions: Drug: rivaroxaban

• Registration Number: NCT02627053
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

Anticoagulant therapy is generally recommended for all patients presenting with acute symptomatic splanchnic vein thrombosis, starting with either low-molecular weight heparin (LMWH) or unfractionated heparin and continuing with the vitamin K antagonists in most patients. Rivaroxaban is approved for the treatment of deep vein thrombosis and pulmonary embolism, but no studies have assessed the safety of rivaroxaban in the setting of splanchnic vein thrombosis. The investigators aim to collect prospective information on the safety of rivaroxaban in a pilot cohort of 100 patients with acute splanchnic vein thrombosis without liver cirrhosis.

Detailed Description

Patients with splanchnic vein thrombosis are at increased risk of recurrent VTE and bleeding. Routine anticoagulation with unfractionated heparin or low molecular weight heparin followed by warfarin is recommended in this setting, but limited data is available to support this recommendation and more than 20% of these patients do not receive antithrombotic treatment due the fear for bleeding complications. The pharmacokinetic and pharmacodynamic characteristics of rivaroxaban make this drug an ideal alternative therapeutic strategy for the treatment of patients with SVT. Thanks to the oral route of administration, the short half-life, the high bioavailability, the predictable dose-response and the lack of effects on platelet activity, rivaroxaban could result as an important alternative to both LMWH and warfarin in the acute and long-term treatment of SVT patients. Furthermore, the analysis of phase III studies conducted in patients with DVT or PE have shown a better safety profile of rivaroxaban as compared to standard of treatment. This observed benefit in the safety profile of rivaroxaban would be extremely relevant in the treatment of patients with SVT. In this prospective cohort study, patients presenting with acute SVT will receive rivaroxaban 15 mg bid for 3 weeks followed by rivaroxaban 20 mg od for a total of 3 months. The primary safety and efficacy outcomes will be measured at 3 months.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-24
• Last Update Posted: 2018-11-27
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rivaroxaban	rivaroxaban	-

Primary Outcome Measures

Name	Time	Method
Major bleeding	3 months

Trial Locations

Locations (4)

University of Western Ontario; 🇨🇦 London, Canada

University of Ottawa; 🇨🇦 Ottawa, Canada

Ospedale di Circolo; 🇮🇹 Varese, Italy

McMaster University; 🇨🇦 Hamilton, Canada