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Rivaroxaban in Thrombotic Antiphospholipid Syndrome (TRAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02157272
Recruitment Status : Terminated (Unbalance in the composite endpoint between arms.)
First Posted : June 5, 2014
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Vittorio Pengo, University of Padova

Brief 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 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.

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.


Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome Drug: Experimental: Rivaroxaban Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Clinical Trial Comparing Rivaroxaban vs Warfarin in High Risk Patients With Antiphospholipid Syndrome
Study Start Date : December 2014
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Rivaroxaban
Rivaroxaban 20mg qd, Rivaroxaban 15mg qd if creatinine clearance between 30-49 ml/min (calculated by Cockroft-Gault equation)
Drug: Experimental: Rivaroxaban
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.
Other Name: Xarelto

Active Comparator: Warfarin
To Keep an INR between 2.0 and 3.0
Drug: Experimental: Rivaroxaban
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.
Other Name: Xarelto




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. • Any single type of thromboembolic event [ Time Frame: up to 4 years ]
  2. All-cause mortality [ Time Frame: up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent form
  2. Male or female of age 18-75 years
  3. 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.
    • 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.
  4. History of thrombosis (objectively proven arterial, venous, and/or biopsy proven microthrombosis) and/or pregnancy morbidity according to Miyaki

Exclusion Criteria:

Subjects meeting any of the following criteria will not be enrolled in the study:

  1. Severe hypersensitivity reaction to rivaroxaban
  2. Calculated CLCR <30 mL/min at the screening visit
  3. 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
  4. 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.
  5. 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.
  6. 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
  7. Known liver cirrhosis or ALT above three times the upper normal value.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157272


Locations
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Italy
University Hospital
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vittorio Pengo, Associate Professor of Cardiology, University of Padova
ClinicalTrials.gov Identifier: NCT02157272    
Other Study ID Numbers: EUDRACT 2013-004575-13
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Keywords provided by Vittorio Pengo, University of Padova:
Antiphospholipid
Syndrome
Rivaroxaban
Warfarin
Thrombosis
Treatment
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Syndrome
Disease
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants