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

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ClinicalTrials.gov Identifier: NCT02627053
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Walter Ageno, 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.

Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Mesenteric Vein Thrombosis Splenic Vein Thrombosis Drug: rivaroxaban Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Portal, Mesenteric, and Splenic Vein Thrombosis With Rivaroxaban. A Pilot, Prospective Cohort Study
Study Start Date : December 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: rivaroxaban Drug: rivaroxaban



Primary Outcome Measures :
  1. Major bleeding [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Consecutive patients aged 18 years or older
  • first episode of symptomatic, objectively diagnosed PVT, MVT, or spVT
  • signed informed consent.

Exclusion criteria:

  • 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
  • Budd-Chiari syndrome
  • previous or ongoing vatical bleeding
  • presence of portal vein cavernoma at the time of diagnosis
  • anticipated abdominal surgical procedure
  • known bleeding diathesis
  • platelet count <100.000 mm3
  • creatinine clearance <30 mL/min (Cockroft-Gault formula)
  • life expectancy of less than 3 months
  • expected inability to take oral medications
  • concomitant treatment with azole antimycotics and human immunodeficiency virus protease inhibitors - treatment with therapeutic doses of LMWH or UFH for more than 7 days
  • ongoing treatment with VKA
  • pregnancy or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627053


Contacts
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Contact: GIOVANNA COLOMBO givacolo@hotmail.it

Locations
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Canada
McMaster University Recruiting
Hamilton, Canada
Contact: Mark Crowther, MD         
University of Western Ontario Recruiting
London, Canada
Contact: Alejandro Lazo-Langner, MD         
University of Ottawa Recruiting
Ottawa, Canada
Contact: Marc Carrier, MD         
Principal Investigator: Aurelien Delluc         
Italy
Ospedale di Circolo Recruiting
Varese, Italy, 21100
Contact: Giovanna Colombo       givacolo@hotmail.it   
Sponsors and Collaborators
Università degli Studi dell'Insubria
Ottawa Hospital Research Institute

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Responsible Party: Walter Ageno, Associate Professor of Medicine, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT02627053     History of Changes
Other Study ID Numbers: RIVASVT-100
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Mesenteric Ischemia
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants