We want to study patients with indication for antithrombotic drugs who suffers from spontaneous intracerebral hemorrhage (ICH). It has long been unclear whether survivors of ICH should start antithrombotic drugs for continued secondary prevention of vaso-occlusive disease or avoid antithrombotic drugs in case it increases the risk of intracerebral hemorrhage.
Conditions
Interventions
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Pharmaceutical Form: Tablet
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient age =18 years. •Spontaneous, primary ICH, of =1 day,, i.e.: oNo 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) oNo ‘secondary’ or underlying structural cause (e.g. haemorrhagic transformation of an ischaemic stroke, aneurysm, tumour, arteriovenous malformation, or intracerebral venous thrombosis) •Patient have 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 atrial fibrillation. •The investigator is uncertain about whether to give or avoid antithrombotic drugs. •Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity, and waiver of consent is accepted in the patients country). •CT or MRI (for patients in MRI sub-study) is performed before randomisation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: •Clear indication for antiplatelet or anticoagulant treatment (e.g. prosthetic heart valves). •Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception. •For patients in MRI substudy: Contraindication for the brain MRI •Malignancy With life expectancy less than 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to estimate the relative and absolute effects of antithrombotic drugs on the risk of recurrent symptomatic ICH associated with a policy of starting antithrombotic drugs after the acute phase of spontaneous ICH.;Secondary Objective: Secondarily, we aim to determine whether there is an interaction between the presence of brain microbleeds on MRI and the effect of antithrombotic drugs on the risk of recurrent ICH. The trial will show whether ICH recurrence is more common among those with more microbleeds, and the extent to wich this is so. ;Primary end point(s): Fatal or non-fatal symptomatic ICH. ;Timepoint(s) of evaluation of this end point: Annually for two years, and after 5 and 10 years . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Functional outcome at two years (according to the modified Rankin Scale) •Death of any cause •Vascular death •Symptomatic epidural, subdural, or subarachnoid haemorrhage •Symptomatic major extracranial haemorrhage •Ischaemic events: transient ischaemic attack, ischaemic stroke, unstable angina, acute myocardial infarction (type 1), peripheral arterial occlusion, mesenteric ischaemia, retinal arterial occlusion, deep vein thrombosis or pulmonary embolism. ;Timepoint(s) of evaluation of this end point: Annually for two years, and after 5 and 10 years . | — |
Countries
Denmark, Norway, Sweden
Contacts
Public ContactTorgeir Bruun Wyller
Oslo University Hospital
Outcome results
None listed