The APACHE-AF Trial Investigators
In patients with atrial fibrillation who survived an anticoagulation-associated intracerebral haemorrhage (ICH) it is unclear whether restarting or avoiding anticoagulation is the best long-term treatment for the prevention of stroke or systemic thromboembolism.
APACHE-AF is a phase II, prospective, randomised, open-label clinical trial with blinded endpoint assessment at 16 hospitals in the Netherlands. We recruited adults with a history of atrial fibrillation and ICH during treatment with oral anticoagulation in whom clinical equipoise existed on the optimal stroke prevention therapy. The target recruitment was 100 participants. Participants were randomised to apixaban 5mg twice daily or to avoiding anticoagulation. We followed participants for the occurrence of vascular death or non-fatal stroke (primary outcome), other vascular events (secondary outcome: all major vascular events) and other serious adverse events. We calculated annual event rates with 95% confidence intervals of the primary outcome in each of the two treatment groups using intention-to-treat analysis, and compared the rates of all-cause death, stroke, ischaemic stroke, ICH, other major haemorrhage, systemic embolism, and functional outcome between participants treated with apixaban and those who are treated with no anticoagulation (antiplatelet drug or no antithrombotic drugs).
Between 16 January 2015 and 6 July 2020, 101 participants (46% female, median age 77 years) were recruited at a median of 46 (IQR 21-74) days after ICH. Participants were followed for a median of 2.2 (IQR 1.0-3.1) years.
Final results will be presented at the conference.
NTR4526; NCT02565693.