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All of the following:
- Men or women (age ≥18 years)
- Symptomatic stroke due to spontaneous (non-traumatic) ICH with all of the following:
- a history from the patient/witness of spontaneous symptom onset without preceding head trauma (head trauma occurring subsequent to ICH symptom onset is permissible)
- brain imaging (CT or MRI) appearances consistent with spontaneous ICH (which may be accompanied by the brain/bone/soft tissue appearances of subsequent trauma)
- thought to be ‘primary’ (i.e. associated with cerebral small vessel disease such as hypertensive arteriopathy or amyloid angiopathy; and an underlying structural cause or secondary cause is not suspected by the investigator or is not detected by further imaging).
- Time since onset of symptoms of ICH exceeds 24 hours
- The optimal timing for starting vs avoiding antiplatelet therapy after ICH onset is uncertain.
- We trust that clinicians will exercise their clinical judgement and only randomise those patients in ASPIRING for whom the clinician has clinical equipoise about the potential benefits and risks of starting vs avoiding antiplatelet therapy.
- For some clinicians and patients, there may not be equipoise until the patient has survived several weeks after ICH (e.g. a large lobar haemorrhage of uncertain cause), whereas for other clinicians and patients there may be equipoise for patients who have only recently experienced an ICH (e.g. a small putaminal haemorrhage due to hypertensive small vessel disease [normal CT angiogram] in a patient with risk factors for ischaemic vascular events and with good control of blood pressure).
- We have elected to have wide entry criteria regarding the range of time after onset of ICH for qualifying for randomisation in ASPIRING in order to capture a wide range of patients with ICH (of variable duration since ICH onset), so that we can determine whether time since ICH onset is a significant modifier of the effect of starting vs avoiding antiplatelet therapy.
- The treating physician is uncertain about whether to start or avoid antiplatelet therapy
- Informed consent obtained
