ISRCTN12580546
Completed
Phase 2
Preventing cognitive decline and dementia from cerebral Small Vessel Disease (Prevent-SVD): a phase II pilot, factorial, randomised, open label blinded end-point trial to investigate short-term effects of cilostazol and isosorbide mononitrate on tolerability, safety, and vascular function in patients with small vessel disease associated stroke. (Lacunar Intervention Trial 1 (LACI-1))
niversity of Edinburgh0 sites57 target enrollmentJuly 5, 2015
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke due to cerebral small vessel disease
- Sponsor
- niversity of Edinburgh
- Enrollment
- 57
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28906205 protocol and statistical analysis plan 2019 Results article in https://doi.org/10.1016/j.eclinm.2019.04.001 results (added 25/06/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31333572 safety data results (added 25/07/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34847709/ (added 17/08/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Mild symptomatic ischaemic stroke compatible with a lacunar ischaemic stroke in the past four years with brain magnetic resonance imaging or CT brain scanning that confirmed the relevant infarct or excluded other cause for symptoms
- •2\. Age \>35 years
- •3\. Independent in activities of daily living (modified Rankin \=2\)
- •4\. Able to give consent (Montreal Cognitive Assessment score 26\-30\)
Exclusion Criteria
- •1\. Other significant acute neurological illness since suffering stroke
- •2\. Age \<35
- •3\. Requiring assistance with activities of daily living (Modified Rankin \=3\)
- •4\. Active cardiac disease (myocardial infarction in past 6 months, active angina, symptomatic cardiac failure)
- •5\. Carotid stenosis \>50% NASCET
- •6\. Contraindication to trial drugs
- •7\. Current use of trial drugs
- •8\. Unable to swallow
- •9\. Bleeding tendency
- •10\. Unlikely to comply with trial medication
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Preventing Cognitive Decline and Dementia from Cerebral Small Vessel Diseaseacunar (small vessel) ischaemic strokeMedDRA version: 19.0 Level: LLT Classification code 10023987 Term: Late effects of cerebrovascular disease System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10068644 Term: Brain stem stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10071043 Term: Basal ganglia stroke System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2015-001953-33-GBniversity of Edinburgh60
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