Skip to content

Antiplatelet Secondary Prevention International Randomised study after INtracerebral haemorrhaGe - SM

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516188-10-00
Enrollment
596
Registered
2025-05-07
Start date
2025-10-07
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral haemorrhage

Brief summary

The first occurrence of any MACE, defined as hospitalisation due to stroke or myocardial infarction, or cardiovascular death

Detailed description

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), 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), Non-cardiovascular death, 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), Hospitalisation due to stroke (ischaemic stroke, ICH, spontaneous subarachnoid haemorrhage, or stroke of unknown pathological type), Hospitalisation due to myocardial infarction, Cardiovascular death, due to any vascular cause, pulmonary embolism, haemorrhage, sudden death, or an unknown cause

Interventions

DRUGClopidogrel Accord 75 mg filmomhulde tabletten

Sponsors

University Of Edinburgh
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The first occurrence of any MACE, defined as hospitalisation due to stroke or myocardial infarction, or cardiovascular death

Secondary

MeasureTime frame
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), 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), Non-cardiovascular death, 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 myoc

Countries

Belgium, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026