Phase II pilot randomised, factorial, short term dose escalation, open label, blinded intermediary endpoint trial, in two hospital centres in the UK, of tolerability and safety of cilostazol, isosorbide mononitrate, both or neither in patients with small vessel disease manifest as symptomatic small subcortical stroke.
Who can participate
Age range35 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
*…
What they're measuring
1
Tolerability proportion of patients able to tolerate the target dose