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An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention - PIONEER AF-PCI

In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.

A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)

The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…

MAGELLaN - Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin

The objective of this study is to demonstrate (1) the superior efficacy of VTE prophylaxis with oral rivaroxaban 10 mg once daily administered for 35 ± 4 days to SC enoxaparin 40 mg once daily (OD) administered for 10 ± 4 days in men and women aged…

A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects with a Recent Acute Coronary Syndrome

The primary objective of the study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke in subjects with a recent ACS compared with…

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.

For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic…

Once-daily oral direct factor Xa rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study.

The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…

An international, multicenter, randomized, double-blind, placebocontrolled
phase 3 trial investigating the efficacy and safety of rivaroxaban
to reduce the risk of major thrombotic vascular events in patients with
symptomatic peripheral artery disease undergoing lower extremity
revascularization procedures

The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

The primary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism.The secondary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on…

A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular
events in patients with coronary or peripheral artery disease (COMPASS - Cardiovascular
OutcoMes for People using Anticoagulation StrategieS)

Primary objectives:*To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces therisk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with…

A multicentre, randomised, double-blind, controlled, phase IIIb study to assess the efficacy and safety of Rivaroxaban 10mg od versus Enoxaparin 4000 IU for VTE PROphylaxis in NOn Major Orthopaedic Surgery. The PRONOMOS study

The primary objective is to demonstrate the non-inferiority of rivaroxaban 10 mg versus enoxaparin 4000 IU relevant to the occurrence of major VTEs up until the end of the treatment (for example, cast or splint removal). The power of the study…

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure

Despite continuous improvements in the medical management of pediatric patients with CHD, the risk of thrombotic events remains an important complication for pediatric patients following the Fontan procedure.The National Heart, Lung and Blood…

Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial

This study has been transitioned to CTIS with ID 2023-506943-40-00 check the CTIS register for the current data. The overall objective of this trial will be to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-…