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FY20 CLINICAL TRIALS - DR . MCCULLOUGH AS PRINCIPAL INVESTIGATOR
In addition to his work on numerous clinical trials , Peter McCullough , MD , MPH , FACC , FACP , FAHA , FCCP , FNKF , FNLA , FCRSA , medical director for cardiovascular research and education for Baylor Scott & White Heart and Vascular Institute has more than 38 citations during 2019 and 2020 in the National Library of Medicine and is the editor-in-chief of Cardiorenal Medicine and Reviews in Cardiovascular Medicine .
ADAPTABLE – To identify the optimal dose of aspirin for secondary prevention in patients with atherosclerotic cardiovascular disease ( ASCVD ). Purpose of the trial : Millions of Americans who have heart disease already take either regular ( 325 mg ) or low-dose ( 81 mg ) aspirin . Even though both doses of aspirin are widely used , no one knows which is better . The goal of ADAPTABLE is to try to find out which dose of aspirin is better for cardiovascular patients .
EXTEND-CRS – MB001-067 A prospective , double blind , placebo controlled , parallel group , randomized trial of extended release exenatide versus placebo in diabetic patients with type 4 cardiorenal syndrome ( EXTEND- CRS TRIAL ) Amendment 1 . The purpose of this research study is to find what effects BYDUREON ® ( EXENATIDE EXTENDED-RELEASE FOR INJECTABLE SUSPENSION ) ® , a currently FDA approved treatment for Type 2 diabetes mellitus , has on heart and kidney function .
FLOW – A trial to evaluate the effect of semaglutide versus placebo on the progression of renal impairment in subjects with Type 2 diabetes and chronic kidney disease ( NN-4321 ).
INVESTED – The study will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than a standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure .
LOWER – A study for patients with homozygous familial hypercholesterolemia . The registry is designed to evaluate the long-term safety and effectiveness of the medication lomitapide in clinical practice for patients with homozygous familial hypercholesterolemia .
SOLOIST – A randomized , double-blind , placebocontrolled , parallel-group multicenter study to evaluate the effects of sotagliflozin on clinical outcomes in hemodynamically stable patients with Type 2 diabetes post worsening heart failure .
VICTORIA – This is a randomized , placebo-controlled , parallel-group , multicenter , double-blind , event driven trial of MK-1242 ( vericiguat ) in subjects with heart failure with reduced ejection fraction ( HFrEF ). The purpose of this study is to test the safety of the study drug , MK-1242 ( vericiguat ) and to test the efficacy effect of the MK-1242 ( vericiguat ) compared with placebo ( dummy tablets ), added to best usual treatment .
SERIES OF ARTICLES ON COVID-19
Throughout the pandemic , Dr . McCullough was sought out for his epidemiologic insight related to the COVID-19 pandemic . He contributed five opinion pieces on the virus to The Hill , a political journalism newspaper and website published in Washington , D . C . The Hill focuses on politics , policy , business and international relations and covers the U . S . Congress , the presidency and election campaigns .
In his April 2 article , COVID-19 is occurring in clusters , making good data and resource allocation crucial , Dr . McCullough reported on challenges with accurately reporting numbers of cases and deaths attributed to the virus , which resulted in paralysis of reallocation of critical resources , such as PPE and ventilators . He recommended these decisions be based on hospitalization data instead .
On April 16 , Dr . McCullough ’ s opinion piece , To know when the peak has passed , we need better COVID-19 modeling , suggested the real epidemiologic measure for the incidence and severity of the virus – hospitalization data . He emphasized healthcare experts need real-time hospital census and numbers of new cases admitted in order to react to the pandemic on a daily basis .
The science behind COVID-19 – and how to guard against infection , Dr . McCullough ’ s May 4 article , examined the role of viral load and dose exposure as determinants of a surge in virus-related hospitalizations in certain geographic areas . He suggested one could reduce his or her own viral load by handwashing , using hand sanitizer , getting fresh air by opening up windows and doors , wearing a mask when with others , and self-quarantining .
Dr . McCullough ’ s June 3 opinion piece , COVID-19 is slowly passing through communities to its unceremonious exit , observed the slowly declining virus activity suggesting we are on a months-toyears course as the virus passes through large populations . He recommended policymakers should turn their attention to hospitalization data , work with hospital and nursing home administrators to make institutions safer , and find age-based suggested standards of practice .
Baylor Scott & White Heart and Vascular Hospital Research and Clinical Trials