Lacunar Intervention Trial 1 (LACI-1)

• Status: Completed
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborator: University of Nottingham
• Treatments: Cilostazol; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

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