Lacunar Intervention Trial 1 (LACI-1) "Prevent-SVD"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Mild symptomatic ischaemic stroke in the past four years compatible with a clinical lacunar stroke syndrome, with brain magnetic resonance imaging or computed tomography scanning that is compatible with a symptomatic small subcortical (lacunar) infarct, or if no recent relevant infarct is visible, that excluded other cause for symptoms
- Age > 35 years
- Independent in activities of daily living (modified Rankin ≤2)
- Able to give consent themselves

Exclusion Criteria

- Other significant active neurological illness present since suffering stroke (eg seizures, multiple sclerosis, brain tumour)
- Age < 35
- Montreal Cognitive Assessment score <26
- Requiring assistance with activities of daily living (Modified Rankin ≥3)
- Active cardiac disease (atrial fibrillation, myocardial infarction in past 6 months, active angina, symptomatic cardiac failure)
- Carotid stenosis > 50% in the symptomatic artery territory requiring carotid endarterectomy (prior and apparently successful carotid endarterectomy is not an exclusion criterion)
- Definite indication for, or definite contraindication to either trial drug
- Unable to swallow
- Bleeding tendency (platelets<100, taking anticoagulant medication)
- Unlikely to comply with trial medication
- Planned surgery during the trial period
- History of intracranial haemorrhage (subdural haematoma, subarachnoid haemorrhage, intracerebral haemorrhage, but not asymptomatic haemorrhagic transformation of infarction)
- Other life threatening illness
- History of drug overdose or attempted suicide or significant active mental illness
- Pregnancy
- If recruited in Edinburgh and participating in cerebrovascular reactivity arm of trial: active respiratory illness (such as moderate to severe asthma or chronic obstructive airways disease), unable to tolerate magnetic resonance imaging or unable to lie flat