Treatment of Splanchnic Vein Thrombosis With Rivaroxaban. A Pilot, Prospective Cohort Study
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ClinicalTrials.gov Identifier: NCT02627053
Recruitment Status : Unknown
Verified November 2018 by Walter Ageno, Università degli Studi dell'Insubria. Recruitment status was: Recruiting
First Posted : December 10, 2015
Last Update Posted : November 27, 2018
Università degli Studi dell'Insubria
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Consecutive patients aged 18 years or older
first episode of symptomatic, objectively diagnosed PVT, MVT, or spVT
signed informed consent.
known liver cirrhosis (biopsy proven or with clinical, laboratory, or imaging evidence of chronic liver disease, within a context of chronic alcoholism, viral hepatitis, autoimmunity, Wilson's disease, iron overload)
alanine aminotransferase level that is three times the upper limit of the normal range or higher
previous or ongoing vatical bleeding
presence of portal vein cavernoma at the time of diagnosis