Completed and ongoing trials of anticoagulation timing after AF-associated ischaemic stroke
Study | Setting and status | Infarct size or severity criteria | Intervention | Control | Primary outcome |
TIMING NCT02961348 | Sweden (completed, 888 participants) | Any severity/size No specific exclusion for HT | Any NOAC 0–4 days | Any NOAC 5–10 days | Recurrent ischaemic stroke, sICH and all-cause mortality at 90 days |
OPTIMAS NCT03759938 | United Kingdom (ongoing, recruitment target=3478) | Any severity/size PH2 HT excluded | Any NOAC 0–4 days | Any NOAC 7–14 days | All-cause stroke and systemic embolism at 90 days |
ELAN NCT03148457 | Europe, Israel, Japan (ongoing, recruitment target=2000) | Infarct size determines intervention timing* PH1 and PH2 HT excluded | Any NOAC Minor-moderate stroke: <48 hours Major stroke: 6–7 days | Any NOAC Minor-moderate stroke: 6–7 days Major stroke: 12–14 days | Recurrent ischaemic stroke, major intracranial and extracranial bleeding, systemic embolism and vascular death at 30 days |
START NCT03021928 | United States (ongoing, recruitment target n=1000) | If infarct size assessable on imaging: infarcts <1.5 cm diameter or >1/2 size of MCA territory excluded If not: NIHSS <5 or >23 excluded | Any NOAC Adaptive design with four study arms: 48–72 hours, 120–144 hours, 216–240 hours, 312–336 hours, | Recurrent ischaemic stroke, sICH, systemic embolism and all-cause mortality at 30 days |
*Infarct size classified as minor (<1.5 cm diameter), moderate (cortical superficial branch of ACA, MCA or PCA, deep MCA branch, internal borderzone territory or multiple minor lesions) or major (complete ACA, MCA, or PCA, or multiple branches of ACA, MCA or PCA, or multiple arterial territories, or posterior circulation lesion ≥1.5 cm diameter).
ACA, anterior cerebral artery; AF, atrial fibrillation; HT, Haemorrhagic transformation; ICH, intracerebral haemorrhage; MCA, middle cerebral artery; NIHSS, National Institutes of Health Stroke Scale; NOACs, non-vitamin K oral anticoagulants; PCA, posterior cerebral artery.