A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation. The purpose of this clinical study is to compare an oral Factor XIa Inhibitor to apixaban in prevention of stroke and non-Central Nervous System systemic embolism (non-CNS SE) in subjects with atrial fibrillation.
Milvexian (JNJ-70033093; BMS-986177) is a direct-acting, reversible, high-affinity inhibitor of activated human
coagulation Factor XI (Factor XIa or FXIa), a serine protease involved in the intrinsic pathway of the coagulation cascade.
Official Title
LIBREXIA-AF: A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Keywords
Atrial Fibrillation
Eligibility
for people 18 Years and up
Inclusion Criteria: Minimum age of 18 years Medically stable and appropriate for chronic antithrombotic treatment Atrial fibrillation eligible to receive anticoagulation Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of a clinical symptomatic stroke. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diab... more
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Inclusion Criteria: Minimum age of 18 years Medically stable and appropriate for chronic antithrombotic treatment Atrial fibrillation eligible to receive anticoagulation Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of a clinical symptomatic stroke. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure Exclusion Criteria: Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study Any condition other than AF that requires chronic anticoagulation
Andrew Rubin, MD holds Board Certifications in Cardiac Electrophysiology, Cardiovascular Disease and Internal Medicine. After completing his internship and residency at The Grad Hospital/University of Pennsylvania, Dr. Rubin earned a Cardiology fellowship at Temple University Hospital and an Electrophysiology fellowship at Lankenau Hospital.
With regard to patient care, Dr. Rubin is heavily influenced by his upbringing. “I was raised in an environment where seeing a doctor was a big dea... more
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Andrew Rubin, MD holds Board Certifications in Cardiac Electrophysiology, Cardiovascular Disease and Internal Medicine. After completing his internship and residency at The Grad Hospital/University of Pennsylvania, Dr. Rubin earned a Cardiology fellowship at Temple University Hospital and an Electrophysiology fellowship at Lankenau Hospital.
With regard to patient care, Dr. Rubin is heavily influenced by his upbringing. “I was raised in an environment where seeing a doctor was a big deal. I appreciate the possible overwhelming atmosphere of a doctor’s office and don’t take for granted what a person is thinking when they meet with me,” states Dr. Rubin. “I see people who are usually in some state of fear — after all, their heart is not working properly and they are scared.” In addition, Dr. Rubin was in a severe car accident in the 1980s and was in and out of the hospital over a couple of years. “I have seen medicine from the other side — as a patient — when you are not well, you are looking for someone to show you empathy,” says Dr. Rubin. At the same time, Dr. Rubin is very up front regarding his patient’s responsibility in their own health care journey. “If you don’t take care of your body, it doesn’t matter what a physician does for you. If you smoke, don’t exercise and eat a lot of sugar, you are not going to regain wellness.”
At Eisenhower Medical Center, Dr. Rubin serves as co-director of Electrophysiology where he oversees Cardiac Research and the Pacemaker Defibrillator Clinic at Eisenhower Desert Cardiology Center, and previously served as Section Chief of Cardiology. He is also director of Cardiology teaching for the Internal Medicine and Family Medicine Residency Programs at Eisenhower Medical Center. He has been honored as the Eisenhower Medical Center Auxiliary Physician of the Year in 2009 and Eisenhower Medical Center Physician of the Month in January 2010.
Furthermore, Dr. Rubin is President and CEO of Genetic Research Institute of the Desert and served as a member of the Steering Committee of the National Institutes of Health Atrial Fibrillation Trial.
Working as principal or co-investigator for more than 63 clinical investigations related to cardiac arrhythmias, Dr. Rubin has peer reviewed more than 18 publications, two book chapters and numerous abstract presentations and clinical presentations. Dr. Rubin was born, raised and trained in Philadelphia. He came to the desert in 1994 after practicing in an academic electrophysiology practice in the Philadelphia region following his training. He remains active in the field of clinical research with special interest in atrial fibrillation and anticoagulation.
