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. 2017 May 25;2017(5):CD012144. doi: 10.1002/14651858.CD012144.pub2

STATICH.

Trial name or title Study of Antithrombotic Treatment after Intracerebral Haemorrhage (STATICH)
Methods Allocation: randomised
Blinding: open, blinded endpoint
Duration: 2 years
Design : parallel
Setting: multicenter in Norway, Denmark, and Sweden
Dates: start up 2017
Participants Inclusion criteria:
  • Spontaneous, primary ICH

  • No preceding traumatic injury, no structural secondary underlying structural cause

  • Indication for antithrombotic drug

  • Uncertainty about whether to start or avoid antithrombotic drugs after ICH

  • Patient age ≥ 18 years

  • Patient is at least 24 hours after symptom onset

  • Consent from patient or representative


Exclusion criteria:
  • Absolute indication for anticoagulant treatment

  • Patient is pregnant, breastfeeding or of childbearing age and not taking contraception

  • Patient is being treated or followed up in another CTIMP


For MRI substudy: contraindication for MRI
Interventions Interventions for each group: the intervention is starting antithrombotic drug. The comparator is avoiding antithrombotic drugs
Outcomes Primary outcome measure: recurrent symptomatic ICH
Secondary outcome measures:
  • complication of qualifying ICH;

  • symptomatic extradural haemorrhage, subdural haemorrhage, subarachnoid haemorrhage;

  • symptomatic major extracranial haemorrhage;

  • symptomatic ischaemic events;

  • cardiovascular death; death from any other cause;

  • mRS

Starting date  
Contact information Trial co‐ordinating investigator: Eivind Berge, MD, PhD, email: eivind.berge@medisin.uio.no
Trial manager: Elisabeth Forfang, MD, email: elisabeth.forfang@medisin.uio.no
Notes  

AF: atrial fibrillation
 CCA: common carotid artery
 CT: computed tomography
 DBP: diastolic blood pressure
 DOAC: direct oral anticoagulant
 ICH: intracerebral haemorrhage
 MRI: magnetic resonance imaging
 mRS: modified Rankin Scale
 NOAC: novel oral anticoagulant
 OAC: oral anticoagulation
 SBP: systolic blood pressure
 TIA: transient ischaemic stroke
 VKA: vitamin K antagonist