September 14, 2021
On 22 July 2021, the ASCOT International Trial Steering Committee (ITSC) made the decision to cease patient enrolment into aspirin-containing arms of the Anticoagulation Treatment Domain of the ASCOT trial. The rationale for removing these treatment arms is that emerging evidence from other platform trials suggests that aspirin does not benefit patients hospitalised with COVID-19.
The UK’s RECOVERY trial has reported results for 14,892 patients that shows there was no benefit of aspirin treatment compared to standard of care treatment. Additionally, the REMAP-CAP trial has reported results via Twitter for 1,467 critically ill patients that also suggests there was no benefit of aspirin treatment compared to standard of care treatment for these patients.
ASCOT is an adaptive platform trial that allows for treatment arms to be added or removed from the study based on findings from the trial interim analyses and from external evidence.
In the month of July, the ASCOT Data Safety and Monitoring Board (DSMB) conducted their first review of the trial interim results. The DSMB recommended that the trial continue, but also suggested that the ITSC consider ceasing the aspirin containing arm in light of the external trial evidence.
In light of the external results and the DSMB comment, the ASCOT Anticoagulation Domain-Specific Working Group and the ASCOT ITSC concluded that aspirin should be removed from the trial.
Patients who have enrolled into the current treatment arm containing aspirin (standard dose low molecular weight heparin plus aspirin) will contribute to a final analysis of the effect of aspirin for patients with COVID-19 enrolled in the ASCOT trial. Regardless of whether a therapeutic agent is effective or not, it is critical that such results are published to inform the medical, scientific and public communities.