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Antiphospholipid SyndromePhase 3TRAPSNCT02157272

Rivaroxaban in Thrombotic Antiphospholipid Syndrome

A Phase 3 study testing Experimental: Rivaroxaban in people with Antiphospholipid Syndrome, run by University of Padova at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR 2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute thrombosis (arterial or venous) confirmed by… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Antiphospholipid Syndrome
What is being tested?
Experimental: Rivaroxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteItaly
Study dates
Dec 2014to 25 Jan 2018
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent form
  • Male or female of age 18-75 years
  • Triple aPL-positivity in the last blood sampling defined as:
  • aCL IgG/M (≥40 GPL or MPL, medium-to-high titer, and/or greater than the 99th percentile) and
  • aB2GPI IgG/M (≥40 U, medium-to-high titer, and/or greater than the 99th percentile) and
  • LA test positive based on the International Society of Thrombosis \& Hemostasis Recommendations.
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  • Positivity of aCL and abeta2GPI must be of the same isotype.
  • To confirm triple positivity for aPL and to validate the laboratory diagnosis, plasma (at least 2ml prepared by double centrifugation at 2000g) from patients of each Center will be stored at -80°C and later on sent in dry ice and retested in a reference laboratory (Padua Thrombosis Centre). Expenses for shipment will be in charge to the coordinator Center.
  • History of thrombosis (objectively proven arterial, venous, and/or biopsy proven microthrombosis) and/or pregnancy morbidity according to Miyaki

Who cannot join

  • Subjects meeting any of the following criteria will not be enrolled in the study:
  • Severe hypersensitivity reaction to rivaroxaban
  • Calculated CLCR <30 mL/min at the screening visit
  • Current pregnancy or breast feeding. Pregnancy is highly discouraged in these patients and if programmed patients are excluded from the study. If sexually active, be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study
  • Concomitant treatment with other anticoagulants, such as unfractionated heparin, low molecular weight heparins (enoxaparin, dalteparin, etc.) heparin derivatives (fondaparinux), other oral anticoagulants (dabigatran etexilate, apixaban) in the case they can not be substituted with the study drugs.
  • Patients taking interfering medications: pharmacologic interactions may occur with strong inhibitors of p-glycoprotein and of CYP3A4, e.g., azole-antimycotics, such as ketoconazole, itraconazole, voriconazole, posaconazole, and HIV protease inhibitors; coadministration of rivaroxaban is therefore contraindicated in these cases. Several drugs used in neurological patients, such as phenobarbital, phenytoin, carbamazepine, and st john's wort (hypericum), are p-glycoprotein inducers and should be avoided. Whenever possible, it would be better to use levetiracetam and topiramate as antiepileptic therapy.
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  • Hemorrhage Risk-Related Criteria
  • History of or condition associated with increased bleeding risk including, but not limited to:
  • Major surgical procedure or trauma within 30 days before the randomization visit
  • Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
  • History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
  • Chronic hemorrhagic disorder
  • Known intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Planned invasive procedure with potential for uncontrolled bleeding.
  • Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg
  • Known liver cirrhosis or ALT above three times the upper normal value.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University Hospital

    Padova, 35128

Other trials in Italy

About this study

Official title: A Prospective, Randomized Clinical Trial Comparing Rivaroxaban vs Warfarin in High Risk Patients With Antiphospholipid Syndrome

Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR 2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleedings, and death in triple aPL-positive APS patients.

Study Design A multicentre, interventional, prospective, parallel, randomised, controlled, open-label, Rivaroxaban 20 mg qd (or 15mg qd in patients with moderate renal insufficiency) vs warfarin (INR target 2.5), non-inferiority study, in 535 triple aPL-positive APS patients in approximately 40 Internal Medicine and Thrombosis centres. Each local Institutional Review Board will approve the study.

Read more

Study Population Patients of both sexes, of age 18-75, affected by anti-phospholipid syndrome, with a high probability of recurrences as defined by triple aPL-positivity, are eligible for this study.

Primary Outcome variables The primary cumulative outcome measure will be incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or death.

Secondary Outcome variables Separate evaluation of arterial and venous thrombosis and all-cause death.

04.27.2015: An amendment has been made. Enrollment permitted till 75 years of age.

Being tested
Experimental: Rivaroxaban
Keywords
Antiphospholipid, Syndrome, Rivaroxaban, Warfarin, Thrombosis, Treatment
Medical subject headings
Antiphospholipid Syndrome, Syndrome, Thrombosis

What participants receive

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

  • Experimental: RivaroxabanDrug

    Also called Xarelto

    The investigated drug is Rivaroxaban 20mg, a film coated tablet, which is a highly selective direct factor Xa inhibitor. It should be administered orally, every day at any time (always the same), with food. The treatment should be performed for all the treatment period.

Study groups in NCT02157272
Study groupRoleWhat they receive
RivaroxabanExperimentalRivaroxaban 20mg qd, Rivaroxaban 15mg qd if creatinine clearance between 30-49 ml/min (calculated by Cockroft-Gault equation)
Receives: Drug: Experimental: Rivaroxaban
WarfarinActive comparatorTo Keep an INR between 2.0 and 3.0
Receives: Drug: Experimental: Rivaroxaban

What is being measured

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

  1. Cumulative outcome measure will be incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or death.

    Measured: up to 4 years

Secondary outcomes (2)

  1. • Any single type of thromboembolic event

    Measured: up to 4 years

  2. All-cause mortality

    Measured: up to 4 years

Timeline

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

  1. First posted5 Jun 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion25 Jan 2018
  4. Study completion25 Jan 2018

Why it stopped: Unbalance in the composite endpoint between arms.

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
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02157272
Sponsor's protocol ID
EUDRACT 2013-004575-13
Acronym
TRAPS
Status last verified
Jan 2018
First submitted
31 May 2014
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Pontara E, Cattini MG, Bison E, Tonello M, Zen M, Vicenzetto C, Giordani A, Baritussio A, Caforio ALP, Pengo V. Assessment of thrombophilia in patients with lupus anticoagulant. Thromb Res. 2025 Oct;254:109474. doi: 10.1016/j.thromres.2025.109474. Epub 2025 Sep 9.

    PubMed 40934736

  • Pontara E, Bison E, Cattini MG, Tonello M, Denas G, Pengo V. Close link between antiphosphatidylserine/prothrombin antibodies, lupus anticoagulant, and activated protein C resistance in tetra antiphospholipid antibody-positive subjects. J Thromb Haemost. 2023 Nov;21(11):3138-3144. doi: 10.1016/j.jtha.2023.06.033. Epub 2023 Jul 7.

    PubMed 37422199

  • Pengo V, Denas G, Zoppellaro G, Jose SP, Hoxha A, Ruffatti A, Andreoli L, Tincani A, Cenci C, Prisco D, Fierro T, Gresele P, Cafolla A, De Micheli V, Ghirarduzzi A, Tosetto A, Falanga A, Martinelli I, Testa S, Barcellona D, Gerosa M, Banzato A. Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood. 2018 Sep 27;132(13):1365-1371. doi: 10.1182/blood-2018-04-848333. Epub 2018 Jul 12.

    PubMed 30002145

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental: Rivaroxaban in people with Antiphospholipid Syndrome, run by University of Padova at 1 site in Italy.

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 16 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: stopped early, as of the sponsor's last update on 30 Jan 2018. 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 Italy. 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 was stopped early (reason given: Unbalance in the composite endpoint between arms.). Results are not available in the source record.

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?

Cumulative outcome measure will be incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or death. (time frame: up to 4 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 NCT02157272, which also lists 3 linked publications.

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 30 Jan 2018.

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