Lacunar Intervention Trial 1 (LACI-1)
Prevent-SVD
Preventing Cognitive Decline and Dementia From Cerebral Small Vessel Disease
3 other identifiers
interventional
57
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedJanuary 19, 2018
January 1, 2018
1.4 years
June 19, 2015
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tolerability proportion of patients able to tolerate the target dose
proportion of patients able to tolerate the target dose
8 weeks
Secondary Outcomes (13)
Safety - bleeding
12 weeks
Safety - recurrent stroke
12 weeks
Safety - death
12 weeks
Safety - blood pressure
8 weeks
Safety - bleeding
8 weeks
- +8 more secondary outcomes
Study Arms (4)
Group 1
ACTIVE COMPARATORIsosorbide mononitrate 25mg bd
Group 2
ACTIVE COMPARATORCilostazol 100mg bd
Group 3
ACTIVE COMPARATORIsosorbide mononitrate 25mg bd and cilostazol 100mg bd start immediately
Group 4
OTHERIsosorbide mononitrate 25mg bd and cilostazol 100mg bd delayed start
Interventions
slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis
phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- University of Nottinghamcollaborator
Study Sites (2)
University of Edinburgh
Edinburgh, EH4 2XU, United Kingdom
University of Nottingham
Nottingham, NG7 2RD, United Kingdom
Related Publications (1)
Blair GW, Janssen E, Stringer MS, Thrippleton MJ, Chappell F, Shi Y, Hamilton I, Flaherty K, Appleton JP, Doubal FN, Bath PM, Wardlaw JM. Effects of Cilostazol and Isosorbide Mononitrate on Cerebral Hemodynamics in the LACI-1 Randomized Controlled Trial. Stroke. 2022 Jan;53(1):29-33. doi: 10.1161/STROKEAHA.121.034866. Epub 2021 Dec 1.
PMID: 34847709DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanna M Wardlaw, MD
University of Edinburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2015
First Posted
June 25, 2015
Study Start
March 1, 2016
Primary Completion
August 1, 2017
Study Completion
November 30, 2017
Last Updated
January 19, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share