Ongoing trials of anticoagulation in patients with AF and previous ICH
Study | Setting | Eligibility criteria | Intervention | Control | Primary outcome(s) |
NASPAF NCT02998905 | Canada | Previous ICH AF, CHADS2 2+ | Any NOAC | Aspirin 81 mg/day | ICH and ischaemic stroke Mean follow-up 1 year |
ASPIRE NCT03907046 | United States | Previous ICH within 14–180 days AF or atrial flutter, CHA2DS2-VASc 2+ | Apixaban | Aspirin 81 mg/day | All-cause stroke and death of any cause within 3 years |
ENRICH-AF NCT03950076 | North America, Europe, Asia | Previous symptomatic intracranial haemorrhage AF, CHA2DS2-VASc 2+ | Edoxaban | Single antiplatelet or no antithrombotic | (1) All-cause stroke, (2) Major haemorrhage, median follow-up 2 years |
PRESTIGE-AF NCT03996772 | Europe | Previous ICH within 6 months AF, CHA2DS2-VASc 2+ (men), 3+ (women) | Any NOAC | Antiplatelet or no antithrombotic | (1) Time to first ischaemic stroke, (2) Time to first ICH, within 3 years |
STATICH NCT03186729 | Europe | Previous ICH AF or vascular disease with antiplatelet treatment indicated | AF: Any anticoagulant No AF: Any antiplatelet | AF: No anticoagulant No AF: No antiplatelet | ICH within 2 years |
A3ICH NCT03243175 | France | Previous ICH AF, CHA2DS2-VASc 2+ |
| Antiplatelet or no antithrombotic, no LAAO | All-cause stroke, major cardiovascular events, and major bleeding, within 2 years |
AF, atrial fibrillation; ICH, intracerebral haemorrhage; LAAO, left atrial appendage occlusion; NOAC, non-vitamin K oral anticoagulant.