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

Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova0 个研究点目标入组 535 人开始时间: 2014年9月19日最近更新: 2015年8月24日

适应症

试验速览

暂无简介。

•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

•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

发起方

Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova