A prospective, randomized clinical trial comparing Rivaroxaban vs warfarin in high risk patients with antiphospholipid syndrome (TRAPS).

• Conditions: THROMBOEMBOLISM PREVENTION; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-004575-13-IT
• Lead Sponsor: Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-19
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

1.Signed and dated informed consent form
2.Male or female of age 18-60 years
3.Triple aPL-positivity in the last blood sampling defined as:
3.1.aCL IgG/M (=40 GPL or MPL, medium-to-high titer, and/or greater than the 99th percentile) and
3.2.aB2GPI IgG/M (=40 U, medium-to-high titer, and/or greater than the 99th percentile) and
3.3.LA test positive based on the International Society of Thrombosis & Hemostasis Recommendations)
3.4.Positivity of aCL and abeta2GPI must be of the same isotype.
4.History of thrombosis (objectively proven arterial, venous, and/or biopsy proven microthrombosis) and/or pregnancy morbidity according to Miyakis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Severe hypersensitivity reaction to rivaroxaban
2.Calculated CLCR <30 mL/min at the screening visit
3.Current pregnancy or breast feeding.
4.Concomitant treatment with other anticoagulants.
5.Patients taking interfering medications: pharmacologic interactions may occur with strong inhibitors of p-glycoprotein and of cyp3a4 and hiv protease inhibitors
6.Hemorrhage Risk-Related Criteria
7.Known liver cirrhosis or ALT above three times
UNV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified