Ongoing and pending clinical trials of anticoagulation restart after intracranial hemorrhage
Sponsor | Eligibility* | Intervention | Primary outcome measure | Follow-up period | Proposed sample size | ||
SoSTART | NCT03153150 | University of Edinburgh | All sICrH (ICH, non-aneurysmal SAH, IVH, SDH) with non-valvular AF and CHA2DS2-VASc ≥2 | Oral anticoagulation (DOAC or VKA antagonist) versus no anticoagulation teatment | Composite event rate: acute coronary, non-fatal stroke or vascular death | 1 year | 800 |
ASPIRE | NCT03907046 | Yale School of Medicine and Yale New Haven Hospital; NINDS | ICH (including IVH), 14–120 days prior, with non-valvular AF and CHA2DS2-VASc ≥2 | Apixaban versus aspirin | Composite event rate: non-fatal hemorrhagic or ischemic stroke or death | 1–3 years | 700 |
STATICH | NCT03186729 | Oslo University Hospital | sICH with antithrombotic indication; stratified by AF (anticoagulant arm) and not (antiplatelet arm) | Anticoagulant treatment versus no treatment | Symptomatic ICH | 2 years | 500 |
A3ICH | NCT03243175 | University Hospital, Lille | sICH with non-valvular AF and CHA2DS2-VASc ≥2 | Apixaban versus LAAC versus neither intervention (standard care with or without antithrombotic treatment) | Composite event rate: fatal and non-fatal, cardiovascular/cerebrovascular, ischemic/hemorrhagic, incracranial/extracranial | 2 years | 300 |
APACHE-AF | NCT02565693 | UMC Utrecht | sICH (including IVH) on anticoagulant treatment | Apixaban versus no antithrombotic treatment | Composite event rate: non-fatal stroke or vascular death | 12–72 months | 100 |
ENRICH-AF | NCT03950076 | Population Health Research Institute | sICrH (IPH, IVH, cSAH) or non-penetrating traumatic SDH, with non-valvular AF and CHA2DS2-VASc ≥2, >14 days ago | Edoxaban versus no anticoagulant | Composite stroke events: ischemic, hemorrhagic, unspecified | 2 years | 1200 |
RESTART-T | NCT04229758 | University of Texas at Austin | Traumatic ICrH and provider intent to reinitiate DOAC therapy | DOAC at 1 vs 2 vs 4 weeks | Composite event rate: hemorrhagic and thromboembolic events | 60 days | 1100 |
*Broad summaries of primary eligibility criteria, excluding multiple inclusion and exclusion.
AF, atrial fibrillation; cSAH, convexal subarachnoid hemorrhage; DOAC, direct oral anticoagulant; ICrH, intracranial hemorrhage; IPH, intraparenchymal hemorrhage; IVH, intraventricular hemorrhage; LAAC, left atrial appendage closure; SDH, subdural hematoma; sICH, spontaneous intracerebral hemorrhage; VKA, vitamin K antagonist.