Abstract
Background and aimsMany patients with prior intracerebral haemorrhage have indications for antithrombotic treatment with antiplatelet or anticoagulant drugs for prevention of ischaemic events, but it is uncertain whether such treatment is beneficial after intracerebral haemorrhage. STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage will assess (i) the effects of long-term antithrombotic treatment on the risk of recurrent intracerebral haemorrhage and occlusive vascular events after intracerebral haemorrhage and (ii) whether imaging findings, like cerebral microbleeds, modify these effects.MethodsSTudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is a multicentre, randomised controlled, open trial of starting versus avoiding antithrombotic treatment after non-traumatic intracerebral haemorrhage, in patients with an indication for antithrombotic treatment. Participants with vascular disease as an indication for antiplatelet treatment are randomly allocated to antiplatelet treatment or no antithrombotic treatment. Participants with atrial fibrillation as an indication for anticoagulant treatment are randomly allocated to anticoagulant treatment or no anticoagulant treatment. Cerebral CT or MRI is performed before randomisation. Duration of follow-up is at least two years. The primary outcome is recurrent intracerebral haemorrhage. Secondary outcomes include occlusive vascular events and death. Assessment of clinical outcomes is performed blinded to treatment allocation. Target recruitment is 500 participants.Trial status: Recruitment to STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is on-going. On 30 April 2020, 44 participants had been enrolled in 31 participating hospitals. An individual patient–data meta-analysis is planned with similar randomised trials.
Highlights
Background and aimsMany patients with prior intracerebral haemorrhage have indications for antithrombotic treatment with antiplatelet or anticoagulant drugs for prevention of ischaemic events, but it is uncertain whether such treatment is beneficial after intracerebral haemorrhage
Antithrombotic treatment is well-established for patients without prior intracerebral haemorrhage (ICH): antiplatelet drugs for the prevention of serious vascular events in patients with vascular disease[1,2] and anticoagulant drugs to prevent systemic embolism in patients with atrial fibrillation,[3,4] among other indications
Randomised controlled trials assessing effects of longterm antithrombotic treatment after ICH are needed for several reasons
Summary
Antithrombotic treatment is well-established for patients without prior intracerebral haemorrhage (ICH): antiplatelet drugs for the prevention of serious vascular events in patients with vascular disease[1,2] and anticoagulant drugs to prevent systemic embolism in patients with atrial fibrillation,[3,4] among other indications. No randomised controlled trials have assessed effects of long-term antithrombotic treatment after ICH.[21] Observational studies have investigated the safety of antiplatelet[18,22,23,24,25,26,27,28] and anticoagulant[8,29,30,31,32,33,34,35,36,37,38] treatment after different types of intracranial haemorrhage including ICH Overall, in these studies, antithrombotic drugs were not associated with an increased risk of recurrent ICH. The secondary aim is to assess whether brain imaging findings, like cerebral microbleeds, modify the effects of antithrombotic treatment after ICH
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