Angiox® (Bivalirudin) Alone Reduced Early Bleeding In ACS Patients Undergoing Angioplasty
VIENNA, AUSTRIA, September 2, 2007-Patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), or angioplasty, experienced nearly 50% less bleeding at 30 days and comparable mortality at one-year when treated with Angiox® (bivalirudin) alone compared to unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor (GPI), according to data from the ACUITY trial. These findings were consistent in patients switched to Angiox monotherapy from unfractionated heparin or enoxaparin. These data were presented today at the European Society of Cardiology (ESC) Congress 2007. The Medicines Company (NASDAQ: MDCO) recently re-acquired rights for Angiox in Europe and currently markets the product as Angiomax® in the United States.
“The ACUITY trial demonstrated that Angiox is the preferred antithrombotic strategy in moderate and high risk ACS patients undergoing PCI. The subgroup analysis presented today gives us compelling new information on the benefits of switching ACS patients to Angiox,” said lead author of the study, Harvey D. White, MD, director of coronary care and cardiovascular research at Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. “The reduction in early bleeding achieved with Angiox monotherapy is particularly important, as bleeding events are commonly linked to late mortality in these patients.”
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.