Aspiring

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Edinburgh

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

7 Oct 2025 → ongoing

Decision date (initial)

2025-11-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Hartstichting

External identifiers

EU CT number

2024-516188-10-00

ISRCTN

ISRCTN16705062

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

ASPIRING will test the hypothesis that starting oral antiplatelet drug monotherapy is superior to avoiding antiplatelet drugs, in addition to standard care at the participating hospital, for increasing the time to first major adverse cardiovascular or cerebrovascular events (MACE) for survivors of stroke due to intracerebral haemorrhage (ICH).

Secondary objectives 6

1. To determine the effects of oral antiplatelet drug monotherapy on major ischaemic events (efficacy)
2. To determine the effects of oral antiplatelet drug monotherapy on major haemorrhage (safety)
3. To determine the effects of oral antiplatelet drug monotherapy on individual components of MACE
4. To determine the effects of oral antiplatelet drug monotherapy on MACE, major ischaemic events and major haemorrhage in clinically important sub-groups
5. To determine the effects of oral antiplatelet drug monotherapy on non-cardiovascular death
6. To determine the effects of oral antiplatelet drug monotherapy on generalisability of the effect on MACE between countries.

Conditions and MedDRA coding

Intracerebral haemorrhage

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Medicines And Healthcare Products Regulatory Agency, South East Scotland Research Ethics Service

Plan to share IPD

Yes

IPD plan description

Identifiable data collected or generated by the trial will not be transferred to any external individuals or organisations outside of the Sponsoring organisations. De-identified data may be shared when the trial is complete to facilitate individual participant data meta-analysis or other analyses that may generate robust evidence to inform the care of stroke survivors.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Stroke due to intracerebral haemorrhage (ICH), diagnosed by brain imaging, with symptom onset at least 24 hours before randomisation.
2. Age ≥18 years at the time of first imaging diagnosis of ICH
3. Radiological text report of the brain imaging study that first diagnosed the ICH is available
4. Consent obtained from the participant (or their representative if the participant lacks mental capacity)

Exclusion criteria 12

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 7

1. 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)
2. 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)
3. Non-cardiovascular death
4. 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)
5. Hospitalisation due to stroke (ischaemic stroke, ICH, spontaneous subarachnoid haemorrhage, or stroke of unknown pathological type)
6. Hospitalisation due to myocardial infarction
7. Cardiovascular death, due to any vascular cause, pulmonary embolism, haemorrhage, sudden death, or an unknown cause

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Edinburgh

Sponsor organisation

University Of Edinburgh

Address

47 Little France Crescent, Bioquarter Bioquarter

City

Edinburgh

Postcode

EH16 4TJ

Country

United Kingdom

Scientific contact point

Organisation

University Of Edinburgh

Contact name

Prof. Catharina JM Klijn

Public contact point

Organisation

University Of Edinburgh

Contact name

Prof. Catharina JM Klijn

Locations

2 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications