Lacunar Intervention Trial 1 (LACI-1)
NCT02481323 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2018-01-19
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.
Conditions
- Cerebral Small Vessel Diseases
- Cognitive Impairment
- Stroke
Interventions
- DRUG
-
isosorbide mononitrate
slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis
- DRUG
-
cilostazol
phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects
Sponsors & Collaborators
-
University of Nottingham
collaborator OTHER -
University of Edinburgh
lead OTHER
Principal Investigators
-
Joanna M Wardlaw, MD · University of Edinburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2017-08-31
- Completion
- 2017-11-30
Countries
- United Kingdom
Study Locations
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