ACTIV-4B trial of antithrombotic therapy in COVID-19 ends early due to low event rates
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The ACTIV-4B trial evaluating antithrombotic therapy in patients with symptomatic COVID-19 has been stopped early due to low event rates, Brigham and Women’s Hospital announced.
The trial, funded by Operation Warp Speed and coordinated by the NHLBI, evaluated low-dose (2.5 mg twice daily) apixaban (Eliquis, Bristol Myers Squibb/Pfizer), high-dose (5 mg twice daily) apixaban, aspirin 81 mg daily and placebo in patients with COVID-19 who were mildly symptomatic but clinically stable without risk factors for thrombotic events.
According to a press release from Brigham and Women’s Hospital, the trial’s Data and Safety Monitoring Board determined the event rates were too low to warrant treatment with antiplatelet or anticoagulant therapy in the study population, and recommended the trial be stopped early.
“This is really good news for the millions of people who are managing mild, stable symptoms of SARS-CoV-2 infections at home,” Paul Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and chairman of the trial, said in the release. “Among mildly symptomatic but clinically stable COVID-19 outpatients a week or more since the time of diagnosis, rates of major cardiopulmonary complications are very low and do not justify preventive anticoagulant or antiplatelet therapy unless otherwise clinically indicated.”
Patients already enrolled will continue to be followed and will be taken off the study medications, according to the release.
The primary efficacy outcome was all-cause mortality, symptomatic venous thromboembolism, MI, stroke, transient ischemic attack, systemic embolism, major adverse limb events or hospitalization for CV or pulmonary cause at 45 days. The primary safety outcome was bleeding events at 45 days.
“The observation that the trial’s primary endpoint rate is exceptionally low is highly actionable from a medical perspective and of considerable clinical importance for the U.S. public,” Jean Connors, MD, hematologist at Brigham and Women’s Hospital and the trial’s principal investigator, said in the release. “We regularly receive questions from physicians caring for mildly symptomatic outpatients about the best pathway forward for these extremely common patients; for those a week or more past the time of COVID-19 diagnosis who are clinically stable and do not have other risk factors, our data show the best course of action is likely not to treat with antithrombotics unless there are other indications for such treatment.”
Investigators will analyze the data and plan to publish it in a peer-reviewed journal, according to the release.
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