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Deep Vein ThrombosisPhase 3RIPORTNCT02555111

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

A Phase 3 study testing Xarelto in people with Deep Vein Thrombosis and Chronic Portal Vein Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Xarelto
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteFrance
Study dates
Sep 2015to Feb 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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"

Who cannot join

  • 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
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  • 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
  • Concomitant treatment by clopidogrel / Plavix® for acute coronary syndrome
  • hepatic transplantation
  • Intra-hepatic shunt

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Beaujon

    Clichy, 92110

Other trials in France

About this study

Official title: Multicentric Randomized Study of Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.

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.

Read the detailed description

Chronic portal vein thrombosis (PVT) is a rare disease, affecting young patients, characterized by permanent obstruction of the portal vein trunk causing portal hypertension. In 60-70% of cases it is related to high risk, moderate or mild prothrombotic risk factors.

Accordingly, there are 2 types of complications from PVT :(i) gastrointestinal haemorrhage related to portal hypertension; and (ii) recurrent thrombosis.

Recurrent thrombosis its most dreaded complication as it may lead to intestinal infarction with a related mortality of 20-60% and a high risk of intestinal insufficiency.

Gastrointestinal haemorrhage related to portal hypertension occurs in 20% patients/year. It is less frequent in patients treated with medical or endoscopic prophylaxis for variceal bleeding.

Retrospective data shows that anticoagulation does not worsen the prognosis, and may conversely improve it. Thus, in patients at risk for gastrointestinal bleeding due to portal hypertension and a mild or moderate risk of recurrent thrombosis, the benefit-risk ratio of anticoagulation therapy is unclear.

The aim of this open randomised trial is to assess the efficacy of Xarelto 15mg/day, a new oral factor Xa inhibitor, in the recurrence of thromboembolic event and the risk of major bleeding compared to an untreated group in patients with chronic portal vein thrombosis without high risk thrombophilia.

The hypothesis of the trial is that treatment with Xarelto® would reduce the risk of recurrence of acute deep vein thrombosis (DVT) regardless location, with limited increase in the risk of hemorrhage in patients with chronic portal thrombosis and no high-risk factors for thrombosis recurrence

This is a national, multicentric, interventional study. 17 french centers already agreed to participate.

296 patients will be included on a 3 years period with 2 to 4 years treatment period. All data will be collected after informed consent will be obtained.

Being tested
Xarelto
Keywords
thrombosis
Medical subject headings
Venous Thrombosis, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XareltoDrug

    Also called Rivaroxaban

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

Study groups in NCT02555111
Study groupRoleWhat they receive
XareltoExperimental15mg/day oral administration during 2 to 4 years (based on the recruitment date).
Receives: Drug: Xarelto
untreatedNo interventionthe patient won't receive any treatment during his study participation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (5)

  1. Efficacy of xarelto

    Assess the efficacy regarding:

    • Incidence of Pulmonary embolism, Deep vein thrombosis, Major bleedings and Portal hypertension bleeding, new non bleeding complication of portal hypertension, minor bleeding,

    Measured: 2 years

  2. Safety of xarelto

    Assess the safety regarding:

    • Toxicity of Xarelto, especially hepatic.
    • Gastrointestinal clinically relevant non major bleedings related to portal hypertension
    • Other gastrointestinal clinically relevant non major bleedings
    • Other adverse events
    • Survival (12months, 24 months and at the end of the follow up).

    Measured: 2 years

  3. Number of hospitalization during follow up.

    Measured: 2 years

  4. Evaluation of clotting activator marker with and without Xarelto.

    Measured: 2 years

  5. Duration of hospitalization during follow up.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02555111
Sponsor's protocol ID
AOM 11077 - P 110150
Other IDs
2015-001190-40, 2015
Acronym
RIPORT
Status last verified
Mar 2020
First submitted
28 Aug 2015
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38319842

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xarelto in people with Deep Vein Thrombosis and Chronic Portal Vein Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of thromboembolic event in any territory ( splanchnic or extra splanchnic, lower limbs, cerebral veinous thrombosis, pulmonary embolism) or death (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02555111, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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