Intracerebral hemorrhage (ICH) is the most severe complication of long-term oral anticoagulation therapy. In ICH survivors the primary reason for using oral anticoagulants for stroke prevention is atrial fibrillation (AF). While oral anticoagulant therapy lowers the risk of ischemic stroke by two-thirds in patients with AF, it may raise the risk of ICH recurrence. Due to lack of robust evidence, the optimal prevention strategy for ICH survivors with comorbid atrial fibrillation remains uncertain.
The PRESTIGE-AF is a randomized controlled trial designed to resolve this uncertainty.
PRESTIGE-AF is an international, phase 3b, multi-center, randomized, open-label study with blinded endpoint assessment designed to compare the efficacy and safety of direct oral anticoagulants versus no oral anticoagulation (either no antithrombotic treatment or a single antiplatelet drug). Participants were included within 12 months of index ICH and a minimum follow-up of 6 months was required. Randomisation occurred in a 1:1 ratio and stratification was based on lobar versus non-lobar location of ICH and sex.  A sample size of 314 patients was assumed adequate to address the research question.
The two co-primary binary endpoints are ischemic stroke and recurrent ICH, which will be analyzed hierarchically in an intention-to-treat approach. Secondary efficacy endpoints are all-stroke and systemic embolism, all-cause and cardiovascular mortality, major adverse cardiac events, and net clinical benefit. Secondary safety endpoints include major hemorrhage and intracranial hemorrhage.
The results from PRESTIGE-AF are anticipated to inform clinical guidelines on the best antithrombotic secondary prevention for ICH survivors with AF and to enable a more personalized approach for this vulnerable patient population.