| Study name |
STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage (STATICH) |
| Methods |
Design: randomised controlled PROBE parallel group trial
Setting: multicentre in Nordic countries
Dates: July 2018 to June 2023 |
| Participants |
Sample size: 500 participants
Diagnosis: ICH
Inclusion criteria
Patient age ≥ 18 years -
Spontaneous ICH, of ≥ 1 day, but not more than 180 days after onset of qualifying ICH, i.e.:
no preceding traumatic brain injury, based on history from the patient/witness of spontaneous symptom onset, and brain imaging appearances consistent of spontaneous ICH (i.e. any brain/bone/soft tissue appearances of trauma must have occurred secondary to a spontaneous ICH) no 'secondary' or underlying structural cause (e.g. haemorrhagic transformation of an ischaemic stroke, aneurysm, tumour, AVM, or intracerebral venous thrombosis)
Patient has indication for antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of ischaemic events, either antiplatelet drugs (for patients with vascular disease), or anticoagulant drug for patients with AF Consent to randomisation from the patient (or personal/legal/professional representative if the patient does not have mental capacity) MRI (or CT) is performed before randomisation
Exclusion criteria
Clear indication for antiplatelet or anticoagulant treatment (e.g. prosthetic heart valves) Contraindications to the antithrombotic drug that will be administered Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception Malignancy with life expectancy less than 2 years
For MRI substudy: contraindication for MRI |
| Interventions |
Intervention: antithrombotic treatment (for patients with vascular disease and indication for antiplatelet drugs: antiplatelet drugs; for patients with AF and indication for anticoagulant drugs: anticoagulant drugs)
Comparator: no antithrombotic treatment |
| Outcomes |
Primary outcome:
Secondary outcomes
mRS score Death of any cause Death of vascular cause Symptomatic epidural, SDH, or SAH (neurological deterioration or death associated with epidural, subdural, or SAH found on CT scan, MRI, or autopsy) Symptomatic major extracranial haemorrhage (clinically overt bleeding associated with one or more of: transfusion of > 2 red cell units of blood; a fall in haemoglobin of 2 g/dL (1.24 mmol/L); bleeding into retroperitoneum, intraocular space or major joint; bleeding leading to permanent treatment cessation) Ischaemic events Cognitive outcome (Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE))
Duration of follow‐up: 2 years |
| Starting date |
1 July 2018 |
| Contact information |
Torgeir Bruun Wyller t.b.wyller@medisin.uio.no
|
| Notes |
Declarations of interest: not specified in trials register
Sources of funding: not specified in trials register |
