CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 363 enrolled
Drug / intervention
Isosorbide Mononitrate XL (ISMN) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03451591
NCT03451591Phase 3Completed

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.

University of Edinburgh·interventional·Posted Mar 2, 2018·Updated Nov 12, 2024

In Brief

A Phase 3 clinical trial evaluating Isosorbide Mononitrate XL (ISMN), Cilostazol, and 2 other interventions for Cerebral Small Vessel Diseases and Stroke, Lacunar. Completed, enrolled 363 participants across 1 site.

Detailed Summary

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. It is thought 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. This not only causes stroke but, perhaps more importantly, causes problems with thinking and walking, possibly causing up to 45% of all dementias either on its own, or mixed with Alzheimer's disease (about 350,000 patients in the UK). 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. The investigators want to 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 2, 2018
Enrollment StartJan 8, 2018
Primary CompletionMay 31, 2022
Study CompletionAug 11, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.3 years ago

Interventions

Isosorbide Mononitrate XL (ISMN)drug

Isosorbide mononitrate (ISMN), is an NO donating organic nitrate that enhances vasodilation, is widely used in ischaemic heart disease, and has no antiplatelet activity.

Cilostazoldrug

Cilostazol is a phosphodiesterase 3-inhibitor (PDE3-inhibitor) that enhances the PGI2-cAMP system. It has weak antiplatelet effects (so low bleeding risk), reduces infarct size and reduces ageing-related decline in myelin repair in experimental models.

ISMN XL and Cilostazoldrug

Cilostazol is a phosphodiesterase 3-inhibitor (PDE3-inhibitor) that enhances the PGI2-cAMP system. It has weak antiplatelet effects (so low bleeding risk), reduces infarct size and reduces ageing-related decline in myelin repair in experimental models. Isosorbide mononitrate (ISMN), is an NO donating organic nitrate that enhances vasodilation, is widely used in ischaemic heart disease, and has no antiplatelet activity.

Neither ISMN nor cilostazolother

Neither isosorbide mononitrate nor Cilostazol administered for the entire duration of the study.