A year ago, researchers set out to study whether symptomatic outpatients with COVID-19 should receive anticoagulant or antiplatelet therapy to prevent clots that were reported in some patients with COVID-19. The data collected so far, using a randomized, double-blind, placebo-controlled trial sponsored by the National Heart, Lung and Blood Institute (NHLBI), suggest a very low rate of thrombotic complications in the patients studied. Trial leadership has found that for patients with mildly symptomatic COVID-19 who have been ill at home for at least one week and who remain clinically stable and have no risk factors for thrombotic events, cardio complication rates -important lungs do not justify antithrombotic therapy. Given these data, the Data Control and Security Board of the study has recommended completing the trial.
“This is good news for the millions of people who manage mild and stable symptoms of SARS-CoV-2 infections at home,” said Paul Ridker, MD, MD, MPH, director of the Cardiovascular Disease Prevention Center. Brigham’s Center and president of the ACTIV-4B COVID-19 outpatient thrombosis prevention trial. “Among patients with mildly symptomatic but clinically stable COVID-19 a week or more from the time of diagnosis, rates of significant cardio-pulmonary complications are very low and do not warrant preventive or antiplatelet therapy unless indicated. contrary “.
As is normal for clinical trials, the ACTIV-4B COVID-19 ambulatory thrombosis prevention trial is overseen by an independent data control and safety board that routinely reviews the data associated with the trial. These review boards are comprised of experts in ethics, biostatistics, and clinical practice essays, and blood clotting disorders. The NHLBI has accepted the recommendations of these oversight boards. As a result, ACTIV-4B has stopped registering, but will continue to monitor study participants, who will withdraw from the medication prescribed by the study. The results of the study will be subsequently analyzed by the researchers and presented for publication in a peer-reviewed journal.
The ACTIV-4B trial included patients with mildly symptomatic but clinically stable COVID-19 who were randomized to one of the four arms. The trial compared 45 days of treatment with prophylactic doses of Apixaban (2.5 mg per bid), therapeutic doses of Apixaban (5.0 mg per bid), aspirin (81 mg per qd), and placebo. po bid). The main outcome of the trial efficacy was a compound of all-cause mortality, symptomatic venous thromboembolism, myocardial infarction, stroke, transient ischemic attack, systemic embolism, major adverse events in the limbs, and hospitalization for cardiovascular or pulmonary at 45 days. The main safety outcome was bleeding at 45 days.
Based on the practice patterns and data available at the time the ACTIV-4B trial was designed, the trial leadership estimated that the risk of the 45-day primary composite endpoint would be 6- 8% in the placebo group. To date, however, there have only been a handful of COVID-related pneumonia hospitalizations and there have been no thromboembolic events among enrolled participants taking study drugs.
“The observation that the primary endpoint value of the trial is exceptionally low is highly applicable from a medical perspective and of considerable clinical importance to the American public,” said Jean Connors, MD, researcher principal of the trial and hematologist at Brigham and Women’s Hospital. “We regularly receive questions from physicians caring for slightly symptomatic outpatients about the best path to these extremely frequent patients; for those who spend a week or more of time diagnosing COVID-19 who are clinically stable and have no other risk factors, our data show that the best course of action is likely not to be treated with antithrombotic drugs unless there are other indications for this treatment. “
“One of the hardest things to do in medicine is to have the confidence to do nothing,” Ridker said. “As the late Bernard Lown, an internationally renowned Brigham cardiologist and Nobel Peace Prize winner, taught us, ‘Do your best for the patient and do the least for the patient.’
Brigham and Women Hospital
Citation: COVID-19 Outpatient Thrombosis Prevention Trial Ends Soon (2021, June 21), Retrieved June 21, 2021 at https://medicalxpress.com/news/2021-06-covid-outpatient-thrombosis- trial-early.html
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