Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apixaban · 1 trial · 1 indication
DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
| Arm | Type | Description |
|---|---|---|
| Enoxaparin | ACTIVE_COMPARATOR | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed. |
| Apixaban | ACTIVE_COMPARATOR | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed. |
| BAY1213790 0.3 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery. |
| BAY1213790 0.6 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery. |
| BAY1213790 1.2 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery. |
| BAY1213790 1.8 mg/kg (post-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery. |
| BAY1213790 0.3 mg/kg (pre-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery. |
| BAY1213790 1.8 mg/kg (pre-surgery) | EXPERIMENTAL | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery. |
| Name | Type | Description |
|---|---|---|
| Enoxaparin | DRUG | 40 mg enoxaparin administered as subcutaneous injection once daily |
| Apixaban | DRUG | 2.5 mg apixaban administered as tablet orally twice daily |
| BAY1213790 | DRUG | Single dose of BAY1213790 administered as intravenous infusion |
Inclusion Criteria: * Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA) * Women of non-childbearing potential Exclusion Criteria: * High risk for clinically significant bleeding * Prior deep vein thrombosis * Body weight above 135 kg * Creatinine cl...
Apixaban is being studied for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. It is an investigational small molecule in Phase 2 clinical development for this indication, evaluated in a completed randomized, double-blind, active-controlled trial.
Apixaban is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 2 clinical development for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty.
Apixaban is in Phase 2 clinical development. It has completed one Phase 2 trial for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. The drug is investigational and not yet approved for this use.
Apixaban has one completed clinical trial, NCT03276143, titled "FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty." This Phase 2 study enrolled 813 participants across multiple countries, including Bulgaria, Canada, Czechia, Greece, Israel, Latvia, Lithuania, Poland, Portugal, Russia, South Africa, Spain, and Ukraine.
Apixaban is the generic name for the drug also marketed as Eliquis. In the context of this clinical development program, Bayer AG is studying apixaban for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty.