The investigators found no significant benefit to patient outcomes when examining time to death, duration of hospitalization, or duration of supplemental oxygen.
Editor’s Note: This story was updated June 7, 2021 to include the publication of results in The Lancet.
Late-breaking clinical trial results provide new insight into how to treat patients who are hospitalized with COVID-19 and at risk for blood clots.
Findings from the ACTION trial, which was led by the Brazilian Clinical Research Institute in collaboration with DCRI’s Renato Lopes, MD, PhD, were presented by Lopes Sunday at the American College of Cardiology’s 70th annual Scientific Session & Expo. Results were also published after the conference in The Lancet.
The ACTION trial randomized 615 patients in Brazil who were hospitalized for COVID-19 and had elevated levels of D-dimer, a biomarker that signals increased risk of blood clots. Patients were assigned to an investigative therapeutic anticoagulation—either rivaroxaban or enoxaparin, depending on patient stability, followed by rivaroxaban for 30 days—or prophylactic anticoagulation of in-hospital heparin. Although therapeutic oral anticoagulation has been proven to help reduce risk of recurrence of blood clots, there was no existing evidence about how these treatments should be administered to patients with COVID-19 prior to this randomized controlled trial.
The investigators, who were examining whether therapeutic anticoagulation decreased time to death, duration of hospitalization, or duration of supplemental oxygen, found no significant difference between the two treatment groups.
The group treated with therapeutic anticoagulation experienced numerically fewer clotting events, but did have higher rates of bleeding.
“To our knowledge, there has been no other randomized controlled trial testing therapeutic oral anticoagulation in patients hospitalized with COVID-19,” Lopes said. “These data add important context to the conversation about how to best treat patients with COVID-19 and suggest that therapeutic oral anticoagulation may not be a good treatment option for these patients.”
The ACTION trial was an output of the Coalition-COVID-19 Brazil initiative, a collaboration among investigators across Brazil to design and conduct trials related to the treatment of patients with COVID-19. In addition to Lopes, DCRI contributors included John Alexander, MD, MHS.