Antiplatelet Secondary Prevention International Randomised study after INtracerebral haemorrhaGe (ASPIRING): an investigator-initiated, multicentre, pragmatic, prospective, randomised, parallel group, open clinical trial of an investigational medicinal product

niversity of Edinburgh0 sites4,148 target enrollmentJuly 15, 2024

Overview

No summary available.

Registry

who.int

Start Date

July 15, 2024

End Date

July 31, 2030

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversity of Edinburgh

•1\. Stroke due to ICH, diagnosed by brain imaging, with symptom onset at least 24 hours before randomisation (i.e. there is no upper limit on the time since ICH onset)
•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)

•1\. ICH due to specific causes:
•1\.1\. Head injury, exclusively, or
•1\.2\. Secondary to aneurysm, angiitis, arteriovenous malformation/fistula, cavernous malformation, coagulopathy, intracranial venous thrombosis, moyamoya disease, or tumour at the time of consent, or
•1\.3\. Haemorrhagic transformation of cerebral infarction at the time of consent.
•2\. Systolic BP \=160 mmHg at randomisation.
•3\. Antithrombotic drug use:
•3\.1\. Oral antiplatelet or oral anticoagulant drug, or aspirin over the counter, were taken within 24 hours before randomisation.
•3\.2\. Investigator believes that prescription of a daily oral antiplatelet drug is required at the time of randomisation.
•3\.3\. Use of all permitted antiplatelet drugs is contraindicated according to their representative Summary of Product Characteristics (SPC) provided with the protocol’s national addendum.
•4\. Follow\-up: