Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xarelto · 6 trials · 1 indication
Complete resolution is characterized as the subject is completely thrombus-free confirmed on transesophageal echocardiography
Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.
Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (\>)1 total subjects were reported.
Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.
| Arm | Type | Description |
|---|---|---|
| Rivaroxaban | EXPERIMENTAL | - |
| Rivaroxaban (Xarelto, BAY59-7939) | EXPERIMENTAL | A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. Rivaroxaban will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with rivaroxaban will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. Rivaroxaban will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion. |
| Vitamin K antagonist (VKA) | ACTIVE_COMPARATOR | A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. VKA will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with VKA will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. VKA will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion. |
| Warfarin | ACTIVE_COMPARATOR | Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 4 | ACTIVE_COMPARATOR | - |
| Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | DRUG | Rivaroxaban 20 mg orally once daily for 6 weeks; subjects with severe to moderate renal impairment (ie, CrCl of 15 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily for 6 weeks in the study. |
| Vitamin K antagonist (VKA) | DRUG | VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards |
| Warfarin | DRUG | Participants orally administered a warfarin potassium tablet (INR \[international normalized ratio\] target was 1.6-2.6 for patients \>70 years and 2.0-3.0 for patients \<70 years) |
| Rivaroxaban placebo | DRUG | Participants orally administered a rivaroxaban placebo tablet |
| Warfarin placebo | DRUG | Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values) |
| Xarelto (Rivaroxaban, BAY59-7939) | DRUG | 10mg od |
| Rivaroxaban (BAY59-7939) | DRUG | 10mg BID, Semi-sequential, dose escalation. |
Inclusion Criteria: * Men or women aged \>/= 18 years * Hemodynamically stable nonvalvular AF or atrial flutter * LA/LAA thrombus documented at baseline by transesophageal echocardiography (TEE) up to 72 hours prior to start of study medication * vitamin K antagonist(s) (VKA)/ new oral anticoagulan...
Rivaroxaban is a small molecule drug being developed for several thromboembolic disorders. Its indications include prevention and control of thromboembolic disorders, pulmonary embolism, superficial vein thrombosis, and pharmacokinetics. It has been studied in clinical trials for the prevention of venous thromboembolism in patients undergoing orthopedic surgery, such as total hip and knee replacement.
Rivaroxaban is developed by Bayer AG, a company traded under the ticker BAYRY. The drug has been investigated in multiple clinical trials, including Phase 3 studies for the prevention of venous thromboembolism and for reducing major cardiovascular events in patients with coronary or peripheral artery disease.
Rivaroxaban is currently listed as being in Phase 1 of clinical development. However, it has completed 10 clinical trials, including several Phase 3 studies. These completed trials have investigated its use for the prevention of venous thromboembolism in surgical patients and for the prevention of major cardiovascular events in patients with artery disease.
Rivaroxaban has been studied in several clinical trials, including NCT00332020, which examined its use in preventing venous thromboembolism after total hip replacement, and NCT00361894, which studied its use after total knee replacement. Another trial, NCT01776424, investigated rivaroxaban for preventing major cardiovascular events in patients with coronary or peripheral artery disease.
Yes, Rivaroxaban is also known as BAY 59-7939. Clinical trials such as NCT00332020 and NCT00361894 refer to the drug as BAY 59-7939 in their titles. These studies investigated the drug for the prevention of venous thromboembolism in patients undergoing elective total hip or knee replacement surgery.