The use of aspirin or clopidogrel for people who survive stroke due to bleeding in the brai
- Conditions
- Stroke due to intracerebral haemorrhage (ICH)Nervous System Diseases
- Registration Number
- ISRCTN16705062
- Lead Sponsor
- niversity of Edinburgh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 4148
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:
4.1. Death appears imminent (very unlikely to survive 1 year after randomisation)
4.2. Follow-up will not be possible for the primary and secondary outcomes
5. Pregnant, breastfeeding, or of childbearing potential and not using highly effective contraception. Birth control methods which may be considered as highly effective include combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, or sexual abstinence
6. Previously enrolled in ASPIRING
7. Enrolled in a study that precludes co-enrolment with ASPIRING
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The first occurrence of any MACE, defined as:<br>1. Hospitalisation due to stroke (ischaemic, haemorrhagic [i.e. ICH or spontaneous subarachnoid haemorrhage (SAH)], or unknown pathological type), or<br>2. Hospitalisation due to myocardial infarction, or<br>3. Cardiovascular death (due to any vascular cause, including pulmonary embolism, haemorrhage, sudden death or death of unknown cause)<br><br>Measured using record linkage to healthcare systems data, telephone interview, or postal/telephone questionnaires between 1 year (minimum) and 5 years (maximum) for each participant according to their time of randomisation before the end of study follow-up
- Secondary Outcome Measures
Name Time Method 1. MACE condition groups (ischaemic MACE and haemorrhagic MACE)<br>2. MACE components (hospitalisation due to stroke, hospitalisation due to myocardial infarction, and cardiovascular death)<br>3. Non-cardiovascular death<br><br>Any additional secondary outcomes are specified in the country-specific national addendum<br><br>Measured using record linkage to healthcare systems data, telephone interview, or postal/telephone questionnaires between 1 year (minimum) and 5 years (maximum) for each participant according to their time of randomisation before the end of study follow-up