Submitted by: Ma. Fe M. Josef 2014-12-20 00:00:00 Last Updated by: Michelle Timban Estera 2014-12-22 14:34:50
Reduced-dosed rivaroxaban in the long-term prevention of recurrent symptomatic VTE
Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the longterm prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism
The Einstein Choice Study
This is a multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven study. Patients with confirmed symptomatic DVT and/or PE who completed 6 to 12 months (± 1 month) of anticoagulant treatment and did not interrupt anticoagulation for longer than 1 week are eligible for this trial.
Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week.
Written informed consent
Legal lower age limitations (country specific)
Indication for therapeutic-dosed anticoagulants
Hypersensitivity to investigational or comparator treatment
Any other contraindication listed in the local labeling for investigational or comparator treatment
Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID)
Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
Calculated creatinine clearance < 30 mL/min
Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Rivaroxaban is an oral, highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban is widely approved in adults for the prevention of venous thromboembolism (VTE) following elective hip or knee replacement surgery, for treatment and secondary prevention of deep-vein thrombosis (DVT) and pulmonary embolism (PE), for the primary and secondary prevention of stroke and systemic non-central nervous system (CNS) embolism in non-valvular atrial fibrillation, and for the prevention of atherothrombotic events after an acute coronary syndrome.
double-dummy, active-comparator, event-driven study
1. The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to acetylsalicylic acid (ASA) 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism).
2. The secondary efficacy objective is to evaluate whether rivaroxaban 10 mg and rivaroxaban 20 mg are superior to ASA 100 mg in the prevention of the secondary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism, myocardial infarction, ischemic stroke,
systemic non-central nervous system [CNS] embolism).
3. The principal safety objective is to document the incidence of the principal safety outcome (i.e. major bleeding).
4. The secondary safety objective is to document the incidence of the secondary safety outcome (i.e. clinically relevant non-major bleeding).
5. Additional study objectives are to evaluate
a. the composite of non-fatal symptomatic venous thromboembolism and all-cause mortality
b. the composite of major bleeding and recurrent venous thromboembolism
c. the composite of major bleeding, recurrent venous thromboembolism, myocardial infarction, ischemic stroke