Recruiting
Phase 3

Rivaroxaban

Sponsor:

Università degli Studi dell'Insubria

Code:

NCT02627053

Conditions

Portal Vein Thrombosis

Mesenteric Vein Thrombosis

Splenic Vein Thrombosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

rivaroxaban

Study Details

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.

Conditions

Portal Vein Thrombosis

Mesenteric Vein Thrombosis

Splenic Vein Thrombosis

Study ID

NCT02627053

Start date

Dec, 2015

Status verified date

Nov, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rivaroxaban

Interventions

rivaroxaban

Primary outcome measure

  • Major bleeding [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

GIOVANNA COLOMBO

givacolo@hotmail.it

Locations

McMaster University

Recruiting

Hamilton, Canada

University of Western Ontario

Recruiting

London, Canada

University of Ottawa

Recruiting

Ottawa, Canada

Principal Investigator:

Aurelien Delluc

More Information

Sponsor

Università degli Studi dell'Insubria

Last update posted

Nov 27, 2018

Last verified

Nov, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Università degli Studi dell'Insubria on 2018-11-27.