ESOC 2021 Session: “Closing Ceremony and Large Clinical Trials 2”
Vignan Yogendrakumar, MD, MSc
@VYogendrakumar
European Stroke Organisation Conference
September 1–3, 2021
Wrapping up our coverage of this year’s ESOC, the second round of results from major clinical trials!
APACHE-AF: Apixaban after Anticoagulation-Associated Intracerebral Hemorrhage In Patients with Atrial Fibrillation: A Randomized, Open-Label, Phase 2 Trial
APACHE-AF was a prospective, randomized, open-label clinical trial, recruiting adults with a history of atrial fibrillation and anticoagulation associated ICH. Following their ICH event (days 7-90 days post ICH event), participants were randomized to apixaban 5mg twice daily or to avoiding anticoagulation. Primary outcome was vascular death or non-fatal stroke and was evaluated using a Cox proportional hazards regression model. Between January 16, 2015 and July 6, 2020, 101 participants (46% female, median age 77 years) were recruited at a median of 46 (IQR 21-74) days after ICH in an intention to treat analysis. Participants were followed for a median of 1.9 (IQR 1.0-3.1) years. There were 10 patients who crossed over. For the primary outcome, comparing Apixaban to Avoiding Anticoagulation: Adjusted HR: 1.05 (0.48-2.31), indicating no major difference between the two groups. There were no major differences in subsequent ICH between the two groups.