Without these clinical trails and research, innovative discoveries within the medical field would not make it to the patients that will benefit from them.
Takeda Factor Xa Reversal Clinical Research Study
The Takeda drug trial is an IRB approved, phase 3, prospective, randomized, open-label, adaptive group sequential, multicenter trial focused on evaluating the efficacy and safety of TAK-330, a reversal agent of factor Xa inhibitors (blood thinners), for patients requiring urgent surgery. Factor Xa inhibitors (blood thinners) are used to prevent blood clots and treat other cardiovascular conditions but can increase bleeding during surgery and other surgical complications. Patient's using these medications directly before urgent surgery require a reversal medication, such as TAK-330, to counteract these effects. This study aims analyze the efficacy and safety of this medication compared to 4-factor prothrombin complex concentrate (4F-PCC), a similar Factor Xa Inhibitor reversal agent already used in hospitals across the United States. It is a 4-week participating study consisting of an initial hospital visit and surgery as well as one follow-up phone conversation with a Denver Metro Orthopedics, P.C. study coordinator.
ROXI-APEX Clinical Research Trial
The ROXI-APEX trial is a Phase 3, multicenter, randomized study sponsored by Regeneron Pharmaceuticals evaluating cenvacibart (REGN7508), an investigational Factor XI monoclonal antibody, for the prevention of venous thromboembolism (VTE) following elective total knee arthroplasty (TKA). VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a potential complication following joint replacement surgery. Cenvacibart is designed to inhibit Factor XI, a protein involved in the blood-clotting process. The study compares cenvacibart with apixaban and enoxaparin, two anticoagulants currently used to prevent blood clots following knee replacement surgery. Participants are followed for approximately 90 days after surgery to evaluate the effectiveness and safety of the study treatments.
ROXI-ASPEN Clinical Research Trial
The ROXI-ASPEN trial is a Phase 3, multicenter, randomized, double-blind study sponsored by Regeneron Pharmaceuticals evaluating cenvacibart (REGN7508), an investigational Factor XI monoclonal antibody, for the prevention of symptomatic venous thromboembolism (VTE) following elective total knee arthroplasty (TKA). The study compares cenvacibart with acetylsalicylic acid (ASA), commonly known as aspirin, which is frequently used for blood-clot prevention following joint replacement surgery. The study aims to determine how effectively cenvacibart prevents complications such as deep vein thrombosis (DVT) and pulmonary embolism (PE), while also evaluating its safety. Participants are followed for approximately 90 days after surgery.
For any questions regarding research conduct or participation, please call Denver Metro Orthopedics, P.C., or reserve an appointment online today.
