Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.

NCT02555111 | Completed Phase 3 DMC

• 2 other identifiers: AOM 11077 - P 1101502015-001190-40
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the recurrence of thromboembolic event compared to an untreated group in patients with chronic portal vein thrombosis without high risk thrombophilia.

Conditions

Deep Vein Thrombosis; Chronic Portal Vein Thrombosis

Keywords

thrombosis

Outcome Measures

Primary Outcomes (1)

• Incidence of thromboembolic event in any territory ( splanchnic or extra splanchnic, lower limbs, cerebral veinous thrombosis, pulmonary embolism) or death

  In patients with chronic portal vein thrombosis without high risk thrombophilia, to assess the efficacy of Xarelto in the recurrence of thromboembolic event compared to absence of treatment.

  2 years

Secondary Outcomes (5)

• Efficacy of xarelto

  2 years

• Safety of xarelto

  2 years

• Number of hospitalization during follow up.

  2 years

• Evaluation of clotting activator marker with and without Xarelto.

  2 years

• Duration of hospitalization during follow up.

  2 years

Study Arms (2)

Xarelto

EXPERIMENTAL

15mg/day oral administration during 2 to 4 years (based on the recruitment date).

Drug: Xarelto

untreated

NO INTERVENTION

the patient won't receive any treatment during his study participation.

Interventions

Xarelto DRUG

15mg/day oral administration during 2 to 4 years (based on the recruitment date).

Also known as: Rivaroxaban

Xarelto

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients aged 18 to 90 years old
• Patients either with :
• Portal cavernoma radiologically confirmed, treated or not by anticoagulant
• previous history of acute portal thrombosis for more than 6 months confirmed by angio-TDM or angio-MRI, repermeabilized or not
• prophylaxis of gastro-intestinal bleeding due to portal hypertension, as recommended for cirrhosis patients. Upper gastro-intestinal endoscopy for less than 12 months
• clinical examination
• for women of childbearing age, contraception, either mecanichal or intra-uterin device, or oral progestative alone. No oral oestroprogestative contraception is allowed.
• written informed consent
• covered by a social security scheme or French "CMU"

You may not qualify if:

• At least one High risk factors of thrombosis recurrence after review by the committee composed of an hepatologist and an hematologist specialist of hemostasis
• Cirrhosis clinically or histologically confirmed or Budd-Chiari syndrome
• Any disease leading to significant coagulopathy and clinically significant bleeding risk (platelets \<50 000, or PT \<30% without VKA, or Factor V \<30% or Fibrinogen \<0,8).
• Personal or familial (1rst degree) history of spontanaeous deep vein thrombosis requiring anticoagulant treatment
• pregnant or breast-feeding women
• History of mesenteric veinous ischemia leading to intestinal resection
• patient infected by HIV and treated by anti-protease
• Formal indication to anticoagulant treatment for any reason
• No possible follow-up
• severe renal injury (creatinin clearance \<30 ml/min)
• Patients receiving a systemic treatment by azoled antifongic agent (such as ketoconazole, itraconazole, voriconazole or posaconazole), or a protease inhibitor. These are strong CYP3A4 and P-gp inhibitors.
• Patients receiving a systemic treatment by rifampicyn or any other strong CYP3A4 inducting/stimulator (phenytoïne, carbamazepine, phenobarbital or millepertuis/Hypericum perforatum)
• Hypersensitvity to rivaroxaban or excipients
• active bleeding, or any condition at risk for significant major bleeding
• Any other concomitant anticoagulant treatment, such as non-fractionnaed heparin, low-molecular weight heparin (enoxaparin, dalteparine, etc…), heparin derivatives (fondaparinux, etc), oral anticoagulant (warfarine, dabigatran etexilate, apixaban, etc) except in case of switch to Xarelto® or, in case of non-fractionnaed heparin administered to maintain central veinous or arterial catheterism permeability

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

Related Publications (1)

• Plessier A, Goria O, Cervoni JP, Ollivier I, Bureau C, Poujol-Robert A, Minello A, Houssel-Debry P, Rautou PE, Payance A, Scoazec G, Bruno O, Corbic M, Durand F, Vilgrain V, Paradis V, Boudaoud L, de Raucourt E, Roy C, Gault N, Valla D. Rivaroxaban Prophylaxis in Noncirrhotic Portal Vein Thrombosis. NEJM Evid. 2022 Dec;1(12):EVIDoa2200104. doi: 10.1056/EVIDoa2200104. Epub 2022 Nov 22.

  PMID: 38319842 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aurélie Dr Plessier

  Hôpital Beaujon - APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 21, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: July 26, 2022

Record last verified: 2020-03

Locations

FR (1)