Study CPAC001A12301 is a pivotal phase III cardiovascular outcomes trial (CVOT) designed to evaluate the efficacy and safety of pacibekitug (PAC001, formerly known as TOUR006 and PF-04236921), a monoclonal antibody (mAb) targeting interleukin-6 (IL-6). The study will assess whether quarterly subcutaneous (s.c.) dosing of 50 mg of pacibekitug, initiated in patients within 30 days after a myocardial infarction (MI) and at high cardiovascular (CV) risk, can significantly reduce the risk of 4-Point Major Adverse Cardiovascular Events (4P-MACE) and Major Adverse Limb Events (MALE) - a composite of CV death, non-fatal MI, non-fatal ischemic stroke, urgent coronar revascularization, acute limb ischemia, major amputation of vascular cause and limb revascularization - as compared to placebo.
Official Title
SITE SELECTED: PINNACLE-MI: A randomized, double-blind, placebo-controlled, multi-center trial assessing the effect of pacibekitug on major cardiovascular events in participants after a myocardial infarction and at high cardiovascular risk
Keywords
Patients with a high cardiovascular (CV) risk that have had a myocardial infarction (MI) within last 30 days.
Eligibility
Patients with spontaneous (type 1) MI within = 12 months of randomization• Patients must be at high CV risk, defined as either•Recent MI (= 30 days of index event presentation at randomization) OR•? 30 days – 12 months of index event presentation at randomization with high-sensitivity C-reactive protein (hs-CRP) = 2mg/L at screening•For all participants, at least two of the following criteria documented in the medical record•Age = 65 years at randomization•Diabetes mellitus (DM) requiring pharma... more
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Patients with spontaneous (type 1) MI within = 12 months of randomization • Patients must be at high CV risk, defined as either •Recent MI (= 30 days of index event presentation at randomization) OR •? 30 days – 12 months of index event presentation at randomization with high-sensitivity C-reactive protein (hs-CRP) = 2mg/L at screening •For all participants, at least two of the following criteria documented in the medical record •Age = 65 years at randomization •Diabetes mellitus (DM) requiring pharmacotherapy •Chronic Kidney Disease (CKD) with eGFR = 15 and = 59 mL/min/1.73 m2 •History of MI prior to the qualifying index event •Multivessel coronary artery disease (CAD) •Cerebrovascular disease (CeVD), comprised of either carotid artery disease or a prior ischemic stroke •Symptomatic peripheral arterial disease (PAD)
Jon Sherman, MD, is Board Certified in Cardiology Diseases and Interventional Cardiology. He has returned to the Coachella Valley, and is seeing patients in Rancho Mirage and Palm Springs with Eisenhower Desert Cardiology Center.After completing medical school at the University of Texas Health Science Center, Houston, Texas, Dr. Sherman completed an Internal Medicine residency program at University of Colorado Health Sciences Center, Denver, Colorado. He then completed a fellowship program... more
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Jon Sherman, MD, is Board Certified in Cardiology Diseases and Interventional Cardiology. He has returned to the Coachella Valley, and is seeing patients in Rancho Mirage and Palm Springs with Eisenhower Desert Cardiology Center.
After completing medical school at the University of Texas Health Science Center, Houston, Texas, Dr. Sherman completed an Internal Medicine residency program at University of Colorado Health Sciences Center, Denver, Colorado. He then completed a fellowship program in Cardiovascular Diseases at Baylor University Medical Center in Dallas, Texas and a fellowship in Interventional Cardiology at Sequoia Hospital in Redwood City, California
Growing up, Dr. Sherman was influenced by several doctors who were his role models. After doing lipid research as a medical student and inspiring experience in the cardiac care unit, Dr. Sherman saw first-hand the newest treatments and innovations being used to save a patients’ lives during cardiac events, and he knew he had found his life’s work.
With regard to care for his patients, Dr. Sherman states, “acknowledging that patients are at various stages of life and have unique life goals, it’s important to recognize the importance of personalizing their care. So, whether it’s a patient seeking prevention of heart disease, helping a patient and their family through an acute emergency and recovery, or someone that is living with chronic cardiac disease, I know that we need to develop an individualized plan that meets their specific healthcare needs.”
