Table 1

Ongoing and pending clinical trials of anticoagulation restart after intracranial hemorrhage

SponsorEligibility*InterventionPrimary outcome measureFollow-up periodProposed sample size
SoSTARTNCT03153150University of EdinburghAll sICrH (ICH, non-aneurysmal SAH, IVH, SDH) with non-valvular AF and CHA2DS2-VASc ≥2Oral anticoagulation (DOAC or VKA antagonist) versus no anticoagulation teatmentComposite event rate: acute coronary, non-fatal stroke or vascular death1 year800
ASPIRENCT03907046Yale School of Medicine and Yale New Haven Hospital; NINDSICH (including IVH), 14–120 days prior, with non-valvular AF and CHA2DS2-VASc ≥2Apixaban versus aspirinComposite event rate: non-fatal hemorrhagic or ischemic stroke or death1–3 years700
STATICHNCT03186729Oslo University HospitalsICH with antithrombotic indication; stratified by AF (anticoagulant arm) and not (antiplatelet arm)Anticoagulant treatment versus no treatmentSymptomatic ICH2 years500
A3ICHNCT03243175University Hospital, LillesICH with non-valvular AF and CHA2DS2-VASc ≥2Apixaban versus LAAC versus neither intervention (standard care with or without antithrombotic treatment)Composite event rate: fatal and non-fatal, cardiovascular/cerebrovascular, ischemic/hemorrhagic, incracranial/extracranial2 years300
APACHE-AFNCT02565693UMC UtrechtsICH (including IVH) on anticoagulant treatmentApixaban versus no antithrombotic treatmentComposite event rate: non-fatal stroke or vascular death12–72 months100
ENRICH-AFNCT03950076Population Health Research InstitutesICrH (IPH, IVH, cSAH) or non-penetrating traumatic SDH, with non-valvular AF and CHA2DS2-VASc ≥2, >14 days agoEdoxaban versus no anticoagulantComposite stroke events: ischemic, hemorrhagic, unspecified2 years1200
RESTART-TNCT04229758University of Texas at AustinTraumatic ICrH and provider intent to reinitiate DOAC therapyDOAC at 1 vs 2 vs 4 weeksComposite event rate: hemorrhagic and thromboembolic events60 days1100
  • *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.