LACunar Intervention (LACI-2) Trial-2: Assessment of safety and efficacy of cilostazol and isosorbide mononitrate to prevent recurrent lacunar stroke and progression of cerebral small vessel disease.
About 35,000 people each year in the UK have a type of stroke, called ‘lacunar’ or ‘small vessel’ stroke, which is different to other common types of stroke and for which there is no proven treatment. We think that small vessel stroke is caused by damage to the lining of the tiny blood vessels deep inside the brain that stops them functioning normally. Some drugs that are commonly used in other blood vessel diseases may help improve small vessel function and prevent worsening of brain damage. One drug (cilostazol) has been tested in patients with stroke in the Asia Pacific countries but not on dementia; the other drug (isosorbide mononitrate) is widely used in the UK for heart disease but not stroke. We have set up a clinical trial to test if the study methods are practical so that patients and trial centres can follow the procedures, and to confirm how many patients have more stroke-like symptoms or experience worsening of their thinking skills. This information is needed to be sure that a very large clinical trial to find out if these drugs can prevent worsening of small vessel disease will be possible.
Chief Investigator: Professor Joanna M Wardlaw
Number and location of participating sites (by region/ country): 26 UK sites
EudraCT number: 2016-002277-35
Funder: British Heart Foundation
Start and End date
Of grant award: March 2018 - August 2022
Of recruitment: January 2018 - May 2021
Current Status: Currently recruiting
Trial Unblinding Information: Outcome assessors will be blinded in this trial. In circumstances where unblinding is necessary please refer to the protocol and follow instructions provided. Please call the LACI-2 helpline for further information on 0131 242 7427.
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Sponsor: University of Edinburgh/NHS Lothian (ACCORD) http://www.accord.ed.ac.uk/
Chief Investigator: Professor Joanna M Wardlaw, Neuroimaging Sciences, University of Edinburgh, Centre for Clinical Brain Sciences (CCBS), Chancellor's Building, 49 Little France Crescent, Edinburgh EH16 4SB; Tel: +44 (0)131 465 9599; Email: Joanna.Wardlaw@ed.ac.uk
Trial Manager: Anna Heye, Edinburgh Clinical Trials Unit, Usher Institute, The University of Edinburgh, Level 2, Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh EH16 4UX; Tel: 0131 651 9917; firstname.lastname@example.org
ECTU Involvement: Trial Management and Follow-Up