ACETYLSALICYLIC ACID for Intracerebral haemorrhage

Inclusion criteria

• {"criterion_text":"- Stroke due to intracerebral haemorrhage (ICH), diagnosed by brain imaging, with symptom onset at least 24 hours before randomisation.\n- Age ≥18 years at the time of first imaging diagnosis of ICH\n- Radiological text report of the brain imaging study that first diagnosed the ICH is available\n- Consent obtained from the participant (or their representative if the participant lacks mental capacity)"}

Exclusion criteria

• {"criterion_text":"- ICH (intracerebral haemorrhage) exclusively caused by head injury.\n- Pregnant, breast-feeding, or of child-bearing potential and not using highly effective contraception\n- Previously enrolled in ASPIRING\n- Enrolled in a study that precludes co-enrolment with ASPIRING\n- ICH secondary to aneurysm, angiitis, arteriovenous malformation/fistula, cavernous malformation, coagulopathy, intracranial venous thrombosis, moyamoya disease, or tumour\n- ICH due to hemorrhagic transformation of cerebral infarction\n- Systolic blood pressure (BP) ≥160mmHg at randomisation\n- Oral antiplatelet or oral anticoagulant drug, or aspirin over the counter, were taken within 24 hours before randomisation\n- Investigator believes that prescription of a daily oral antiplatelet drug is required at the time of randomisation\n- Antiplatelet drug use is contraindicated\n- Death appears imminent\n- Follow-up will not be possible for the primary and secondary outcomes"}

Primary endpoints

• {"endpoint_text":"- The first occurrence of any MACE, defined as hospitalisation due to stroke or myocardial infarction, or cardiovascular death","definition_or_measurement_approach":"Defined as: hospitalisation for a symptomatic stroke (ischaemic stroke, haemorrhagic stroke [such as ICH or subarachnoid haemorrhage], or stroke of unknown pathological type), or hospitalisation for myocardial infarction, or death due to a vascular cause (including sudden death, pulmonary embolism, haemorrhage, or death of unknown cause)."}

Secondary endpoints

• {"endpoint_text":"- Major ischaemic events leading to hospitalisation or death (i.e. ischaemic stroke, myocardial infarction, pulmonary embolism, or peripheral arterial occlusion causing critical limb ischaemia or mesenteric ischaemia)","definition_or_measurement_approach":"Major ischaemic events resulting in hospitalisation or death; examples listed in parentheses specify event types to be captured (ischaemic stroke, myocardial infarction, pulmonary embolism, peripheral arterial occlusion causing critical limb or mesenteric ischaemia)."}
• {"endpoint_text":"- Major haemorrhage leading to hospitalisation or death (i.e. symptomatic bleeding from the gastrointestinal tract, lungs, uterus, urinary tract, or in critical area or organ defined for non-surgical patients by the International Society of Thrombosis and Haemostasis: intracranial [exclusively extradural, subdural, or intraventricular], intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intramuscular with compartment syndrome, or another organ)","definition_or_measurement_approach":"Major haemorrhage resulting in hospitalisation or death; includes symptomatic bleeding from specified sites and critical areas/organs as defined by ISTH."}
• {"endpoint_text":"- Non-cardiovascular death","definition_or_measurement_approach":"Death not due to a vascular/cardiovascular cause."}
• {"endpoint_text":"- Non-hospitalized major adverse cardiovascular or cerebrovascular events (MACE); defined as MACE for which a patient was required to be seen in the emergency room but did not require a hospital-admission (ischaemic stroke, haemorrhagic stroke, stroke of unknown pathological type, or myocardial infarction)","definition_or_measurement_approach":"MACE events requiring emergency room attendance but not hospital admission; includes ischaemic stroke, haemorrhagic stroke, stroke of unknown type, or myocardial infarction."}
• {"endpoint_text":"- Hospitalisation due to stroke (ischaemic stroke, ICH, spontaneous subarachnoid haemorrhage, or stroke of unknown pathological type)","definition_or_measurement_approach":"Hospital admission due to a stroke event; stroke subtypes specified."}
• {"endpoint_text":"- Hospitalisation due to myocardial infarction","definition_or_measurement_approach":"Hospital admission with a primary diagnosis of myocardial infarction."}
• {"endpoint_text":"- Cardiovascular death, due to any vascular cause, pulmonary embolism, haemorrhage, sudden death, or an unknown cause","definition_or_measurement_approach":"Death attributed to a vascular/cardiovascular cause, including pulmonary embolism, haemorrhage, sudden death, or unknown cause presumed vascular."}

Methods

• K1_Recruitment arrangements (documented recruitment arrangements)
• GP invitation/notification letters for Belgium (K2_Letter_GP_BE_FR, K2_Letter_GP_BE_NL)
• Patient invitation letter (K2_Recruitment material patient invitation letter)
• Recruitment videos (K2_Recruitment_Material_video Dutch and French; translated versions referenced)
• Fast-facts patient leaflets in Dutch and French (K2_Recruitment_Material_Fast_facts_FR, K2_Recruitment_Material_Fast_facts_NL)

Netherlands

Earliest CTIS Part Ii Submission Date

21-04-2025

Latest Decision Or Authorization Date

07-05-2025

Processing Time Days

16

Number Of Sites

17

Number Of Participants

356

Belgium

Earliest CTIS Part Ii Submission Date

04-11-2025

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

13

Number Of Sites

12

Number Of Participants

240

Primary sponsor

Full Name

University Of Edinburgh

Organisation Type

Educational Institution

Country Of Registered Address

United Kingdom