Intracerebral Hemorrhage
Conditions
Interventions
Intervention Group:Start antiplatelet monotherapy
Control Group:Avoid antiplatelet therapy
Sponsors
The George Institute for Global Health (Australia) Beijing Representative Office
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. No gender limits, aged >= 18 years. 2. 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 brain/bone/soft tissue appearances of trauma occurring subsequently); thought to be primary (an underlying structural cause is not suspected by the investigator, or is not detected by further imaging); time since onset of symptoms of ICH exceeds 24 hours. 3. The treating physician is uncertain about whether to start or avoid antiplatelet monotherapy. 4. Informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. ICH due to head injury, in the opinion of the investigator. 2. ICH secondary to structural causes, such as aneurysm, arteriovenous malformation, cerebral cavernous malformation, and tumour; or other secondary causes such as cerebral vein thrombosis and arteritis(ICH due to haemorrhagic transformation of an acute ischaemic stroke, in the opinion of the investigator). 3. ICH symptom onset was within the last 24 hours. 4. Patient is taking an antithrombotic drug (including immobile patients anticoagulated for the prevention of venous thromboembolism) or traditional Chinese medicine (TCM), herbal or Ayurvedic medicine, with antiplatelet or anticoagulant properties (including: ginkgo, Asian ginseng/red ginseng, danshan, safflower, turmeric, curcuma, Szechuan, cordalls and Chinese motherwort) following ICH, unless the patient, doctor and, if possible, prescribing doctor believe it is appropriate to discontinue use. 5. Not available for follow-up over the next 1-3 years (e.g. no fixed home address). 6. Other life-threatening illness (e.g. advanced cancer) that makes it unlikely for the patient to survive longer than one year. 7. Pregnant, breast-feeding or of child-bearing potential and not using contraception. 8. Enrolled in another interventional clinical research trial involving another investigational product (medicine) or device in which the steering committee of the other trial does not permit co-enrolment of patients in their trial into another trial (such as ASPIRING). If the other trial permits co-enrolment, then the patient can be enrolled also in ASPIRING.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of all serious vascular events (non-fatal stroke [including ICH], non-fatal myocardial infarction, or death from a vascular cause).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Haemorrhagic events(Intracerebral haemorrhage,Intracranial (but extracerebral) haemorrhage,Extracranial haemorrhage);Vaso-occlusive events;Events of uncertain pathological type;Death;Adherence to antiplatelet monotherapy;Incident atrial fibrillation;Montreal Cognitive Assessment (MoCA) 5-minute;Simplified modified Rankin scale (smRSq);Health-related quality of life (HRQoL);Short Informant Questionnaire on Cognitive Decline in the Elderly (short IQCODE); | — |
Countries
China
Contacts
Public ContactCraig Anderson
The George Institute for Global Health (Australia) Beijing Representative Office
Outcome results
None listed