NCT02627053

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

3.5 years

First QC Date

December 7, 2015

Last Update Submit

November 24, 2018

Conditions

Portal Vein ThrombosisMesenteric Vein ThrombosisSplenic Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Major bleeding

    3 months

Study Arms (1)

rivaroxaban

EXPERIMENTAL
Drug: rivaroxaban

Interventions

rivaroxabanDRUG
rivaroxaban

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

McMaster University

Hamilton, Canada

RECRUITING

University of Western Ontario

London, Canada

RECRUITING

University of Ottawa

Ottawa, Canada

RECRUITING

Ospedale di Circolo

Varese, 21100, Italy

RECRUITING

Related Publications (1)

  • Ageno W, Beyer Westendorf J, Contino L, Bucherini E, Sartori MT, Senzolo M, Grandone E, Santoro R, Carrier M, Delluc A, De Stefano V, Pomero F, Donadini MP, Tosetto A, Becattini C, Martinelli I, Nardo B, Bertoletti L, Di Nisio M, Lazo-Langner A, Schenone A, Riva N. Rivaroxaban for the treatment of noncirrhotic splanchnic vein thrombosis: an interventional prospective cohort study. Blood Adv. 2022 Jun 28;6(12):3569-3578. doi: 10.1182/bloodadvances.2022007397.

    PMID: 35439303DERIVED

MeSH Terms

Conditions

Mesenteric Ischemia

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPeritoneal DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

GIOVANNA COLOMBO

CONTACT

givacolo@hotmail.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 10, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

IT(1)CA(3)