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CompletedNCT03451591LACI-2Updated Nov 12, 2024Results posted

LACunar Intervention (LACI-2) Trial-2

A Phase 2/3 interventional study of Isosorbide Mononitrate XL (ISMN) and Cilostazol in Cerebral Small Vessel Diseases and Stroke, Lacunar, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.

Primary conditionStroke, LacunarRegistry: Cerebral Small Vessel DiseasesReclassifiedWhy we changed it
Registry
Cerebral Small Vessel Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Stroke, Lacunar
Why
  1. The study's listed conditions name Stroke, Lacunar, a narrower term within Cerebral Small Vessel Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Edinburgh · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
363
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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.

Read the detailed description

A quarter of all ischaemic strokes (about 35000 per annum in the UK) are lacunar (small vessel) in type, mainly caused by an intrinsic, non-atheromatous, non-cardioembolic disease of the small deep perforating cerebral arterioles. More diffuse cerebral small vessel disease also causes up to 45% of dementias (350,000+ patients estimated currently in the UK), either alone or in association with Alzheimer's disease. There is no proven treatment for cerebral small vessel disease: conventional antiplatelet drugs may be ineffective or even hazardous, whilst antihypertensive treatment and statins may not have an effect. The disease mechanism is poorly understood but endothelial dysfunction, blood-brain barrier failure and vessel stiffness appear to contribute to the pathogenesis. Promising data available for licensed drugs with relevant modes of action, cilostazol (>6000 stroke patients in the Asia Pacific Region) and isosorbide mononitrate (ISMN, widely used in cardiac disease) support their testing in cerebral small vessel disease. This trial will be an Phase IIb preparatory to Phase III, randomised, partial factorial, open label, blinded end-point trial, testing cilostazol, ISMN, both, or neither, to assess the feasibility of recruitment, drug tolerability, trial procedures, safety and event rates in 400 patients recruited in UK stroke centres and followed-up to one year (primary endpoint). This trial is preparatory to a large, definitive, Phase III randomised controlled trial to prevent recurrent lacunar stroke and progressive small vessel disease-related physical and cognitive impairments after lacunar stroke.

02

Conditions studied

  • Cerebral Small Vessel Diseases
  • Stroke, Lacunar

Browse trials for

Keywords

  • Cerebral Small Vessel Diseases
  • Stroke, Lacunar
  • Dementia
  • Alzheimer's disease
03

In context

Stroke, Lacunar Reclassified

21 studies on the registry are indexed under Stroke, Lacunar; 9 are open to participants now.

This study's enrollment of 363 is above the median of 60 across 15 interventional studies indexed under Stroke, Lacunar.

Browse Stroke, Lacunar studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.

Browse University of Edinburgh studies →

Compared within Stroke, Lacunar, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cerebral Small Vessel Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical lacunar stroke syndrome.

  • Brain scanning* with MR including diffusion imaging wherever possible, and obtained soon after the presentation with stroke, shows either:

    • a recent, relevant (in time and location) acute lacunar infarct on diffusion MR imaging1,
    • or, if no visible acute lacunar infarct on diffusion MR imaging2 then there is no competing pathology as a cause for stroke (e.g. no acute cortical infarct, no acute intra-cerebral haemorrhage, no stroke mimic such as tumour, subdural haematoma);

    • or, if only a CT brain scan is available2 as in section 3 above, then there is a small relevant (in age and location) subcortical infarct, or if no infarct then there is no competing pathology as a cause for stroke (e.g. no acute cortical infarct, no acute intra-cerebral haemorrhage, no stroke mimic such as tumour, subdural haematoma).

      1. Note that if there is no acute lacunar infarct on MR diffusion imaging but there is a recent-appearing lacunar infarct on FLAIR, T2, or T1 (i.e. no cavitation or ex-vacuo effect; may be slightly swollen, ill-defined edges; or scan in the few weeks before the stroke does not show a lesion but there is an acute lacunar infarct on MR T2, FLAIR, T1 scanning after the stroke in an appropriate area of the brain for symptoms), then the T2, FLAIR, T1 lesion may be counted as the acute lacunar infarct in the absence of a diffusion lesion. Similarly, on CT2 a recent relevant small subcortical infarct would not show cavitation or shrinkage/ex vacuo effect.
      2. Note that about a third of patients with a clinically definite lacunar syndrome do not have a corresponding recent infarct visible on MRI but should still be classed as 'lacunar stroke' if no other explanation can be found for the symptoms. The presence of a recent cortical infarct on FLAIR, T2, T1, the recent timing being indicated by the characteristics above, would count as a competing pathology.

Note that the complete absence of any abnormality on MR or CT brain imaging (no acute subcortical infarct or pre-existing SVD such as white matter hyperintensities, lacunes, etc.) while occasionally seen in lacunar stroke is unusual and should question the diagnosis of lacunar ischaemic stroke.

  • Age > 30 years
  • Independent in activities of daily living (modified Rankin ≤2)
  • Capacity to give consent themselves

Exclusion criteria

Exclusion Criteria:

  • Other significant active neurological illness present since suffering stroke (e.g. recurrent seizures, multiple sclerosis, brain tumour). Well-controlled epilepsy present prior to the stroke, a single seizure at onset of the stroke or provoked seizure is not an exclusion.
  • Requiring assistance with activities of daily living (Modified Rankin ≥3)
  • Has been diagnosed as having dementia on formal clinical assessment
  • Active cardiac disease (atrial fibrillation, myocardial infarction in past 6 months, active angina, symptomatic cardiac failure)
  • Diagnosis of hypotension, defined as sitting systolic blood pressure less than 100mmHg
  • Definite indication for (i.e. already prescribed) either trial medication, or definite to a trial drug as per SPCs - lactose intolerance is a contraindication to ISMN preparations which contain lactose monohydrate - (indication for or contraindication to one of the trial drugs still allows randomisation to the other trial drug)
  • Unable to swallow tablets
  • Bleeding tendency (e.g. known \<100, active peptic ulcer, history of intracranial haemorrhage such as subdural haematoma, subarachnoid haemorrhage, intracerebral haemorrhage, but not asymptomatic haemorrhagic transformation of infarction or a few microbleeds, taking anticoagulant medication)
  • Planned surgery during the trial period including carotid endarterectomy. Note prior and apparently successful carotid endarterectomy (or other surgery) is not an exclusion criterion and patients who would otherwise be eligible but require endarterectomy first may be randomised after recovery from successful endarterectomy.
  • Other concurrent life threatening illness
  • Unlikely to be available for follow-up (e.g. moving outside or visitor to the area)
  • History of drug overdose or attempted suicide or significant active mental illness
  • Pregnant or breastfeeding women, women of childbearing age not taking . Acceptable contraception in women of childbearing age is a "highly effective" contraceptive measure as defined by the Clinical Trials Facilitation Group (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and includes combined (oestrogen and progesterone containing) or progesterone-only contraception associated with inhibition of ovulation, or intrauterine device or bilateral tubal occlusion. Contraception must be continued for up to 30 days after the end of the IMP dosing schedule.
  • Prohibited medications to either trial drug (see sections 4.5 of the appended SPCs and protocol section 6.6.3, plus no anticoagulant drugs); (prohibited medications to one of the trial drugs still allows randomisation to the other trial drug).
  • Renal impairment ( \<25 ml/min)
  • Hepatic impairment
  • Current enrolment in another Clinical Trial of Medicinal Product (CTIMP); still in extended follow-up beyond the CTIMP primary outcome and no longer taking that trial's IMP is not an exclusion to enrolment in LACI-2.
  • Unable to tolerate MRI or contraindication to MRI (Claustrophobia, Pacemaker)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
363 participants (actual)

Study arms

  • Active comparator
    Isosorbide Mononitrate XL (ISMN)

    Oral Isotard® 25mg XL (Isosorbide Mononitrate) tablets. Oral Isotard® 25mg XL: Day 1-5 / 25mg daily morning dose. Day 6 to week 52 / 50mg daily morning dose. Week 53 / 25mg daily morning dose. Week 54 / NIL dose. Or Oral Isosorbide mononitrate (ISMN) non-XL 20mg tablets: Day 1-5 / 20mg daily evening dose. Day 6 to week 52 / 20mg twice daily morning \& evening. Week 53 / 20mg daily morning dose. Week 54 / NIL dose.

    Drug: Isosorbide Mononitrate XL (ISMN)

  • Active comparator
    Cilostazol

    Oral Cilostazol 100mg tablets. Day 1-5 / 50mg daily evening dose. Day 6-10 / 50mg twice daily morning \& evening. Day 11-15 / 50mg daily morning dose \& 100mg daily evening dose. Day 16 to week 52 / 100mg twice daily morning \& evening. Week 53 / 50mg twice daily morning \& evening. Week 54 / NIL dose.

    Drug: Cilostazol

  • Active comparator
    ISMN XL and Cilostazol

    Oral Isotard® 25 mg XL (ISMN) and oral Cilostazol 100mg tablets. Day 1-5 / ISMN - 25mg daily evening dose / Cilostazol - NIL. Day 6-10 / ISMN - 50mg daily morning dose and Cilostazol - NIL. Day 11-15 / ISMN - 50mg daily morning dose / Cilostazol - 50mg daily evening dose. Day 16-20 / ISMN - 50mg daily morning dose and Cilostazol - 50mg twice daily morning \& evening. Day 21-25 / ISMN - 50mg daily morning dose and Cilostazol - twice daily, 50mg morning \& 100mg evening dose. Day 26-30 ISMN - 50mg daily morning dose and Cilostazol 100mg - twice daily morning \& evening. Day 30 to week 52 / ISMN 50mg morning dose and Cilostazol 100mg - twice daily morning \& evening. Week 53 / ISMN 25mg daily morning dose and Cilostazol 50mg twice daily morning \& evening. Week 54 / NIL dose

    Drug: ISMN XL and Cilostazol

  • Placebo comparator
    Neither ISMN nor cilostazol

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

    Other: Neither ISMN nor cilostazol

Interventions

  • DrugIsosorbide Mononitrate XL (ISMN)

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

    Also known as: Isosorbide mononitrate non-XL (ISMN)

  • DrugCilostazol

    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.

  • DrugISMN XL and Cilostazol

    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.

    Also known as: isosorbide mononitrate non-XL and cilostazol

  • OtherNeither ISMN nor cilostazol

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

06

What researchers measure

Primary outcomes

  1. Feasibility of Phase III Trial

    Feasibility of Phase III trial, i.e. that eligible patients can be identified correctly, in sufficient numbers, enrolled and \>95% retained in follow-up at one year, to achieve feasibility target sample size recruitment and randomisation of 400 patients in 24 months in the UK.

    Time frame: 36 months (24 Months Recruitment + 12 months Follow Up)

Secondary outcomes

  1. Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year

    It is estimated that in this trial 75% of patients will be able to tolerate trial medication, in at least half dose, up to one year after randomisation (i.e. less than 25% will stop trial medication completely through inability to tolerate the drugs).

    Time frame: 12 months

  2. Incidence of Treatment Emergent Adverse Effects [Safety]

    Safety - symptoms of systemic or intracranial bleeding, recurrent cerebral and systemic vascular events, and vascular and non-vascular causes of death will be collected. It is estimated that in this trial the absolute risk of death, including fatal haemorrhage, will not differ significantly (ie fall outside the upper 95% CI) from 2% per year on trial drugs versus no trial drugs, when given in addition to guideline drugs; and will not increase bleeding or ischaemic SVD lesions significantly (at the p\<0.01 level) on MRI.

    Time frame: 12 months

  3. Treatment Efficacy - Percentage of Participants Experiencing an Event (Stroke, TIA, Myocardial Ischaemia, Cognitive Impairment and Dementia)

    It is estimated that in this trial the combined rate of recurrent stroke, MI, death, cognitive impairment and dependency will be 40-50% at one year after enrolment in order to detect modest but clinically-important reductions in poor outcomes. The study has a 2x2 partial factorial design. This allows testing of both drugs when given alone and together. Participants were allocated into one of four treatment groups. However, as some participants were in a group which received both treatments simultaneously then the subgroups reported for IMP exposure include a count of both participants from the single and the combined treatment groups as the total number exposed to that IMP

    Time frame: 12 months

07

Results

Posted Nov 12, 2024
Limitations and caveats
The open label design may have facilitated bias, though there is no evidence for this. The follow-up co-ordinators were masked to allocated drug whilst recording outcome data. Recruitment and one year follow-up at sites in LACI2 was affected by the SARS-Cov-19 pandemic. Some patients were unable to return for MRI or in person assessments at sites (Trails, BP) or return postal follow-up forms. As a factorial trial, comparison of the combination of drugs versus no drugs was underpowered.

Participant flow

Randomisation
Participant flow — Randomisation
MilestoneIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor Cilostazol
Started90919191
Completed90919191
Not completed0000
SAE Reporting - Exposure to IMP
Participant flow — SAE Reporting - Exposure to IMP
MilestoneIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor Cilostazol
Started1811829191
Completed1811829191
Not completed0000
Randomisation to 12 Month Follow Up
Participant flow — Randomisation to 12 Month Follow Up
MilestoneIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor Cilostazol
Started90919191
Completed70708187
Not completed2021104

Outcome measures

PrimaryFeasibility of Phase III Trial

Feasibility of Phase III trial, i.e. that eligible patients can be identified correctly, in sufficient numbers, enrolled and \>95% retained in follow-up at one year, to achieve feasibility target sample size recruitment and randomisation of 400 patients in 24 months in the UK.

Time frame:
36 months (24 Months Recruitment + 12 months Follow Up)
Reported as:
Count of participants · Participants
Feasibility of Phase III Trial
ParticipantsIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor Cilostazol
Feasibility of Phase III Trial2021104
SecondaryTrial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year

It is estimated that in this trial 75% of patients will be able to tolerate trial medication, in at least half dose, up to one year after randomisation (i.e. less than 25% will stop trial medication completely through inability to tolerate the drugs).

Time frame:
12 months
Reported as:
Count of participants · Participants
Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year
ParticipantsIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and Cilostazol
Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year594845
SecondaryIncidence of Treatment Emergent Adverse Effects [Safety]

Safety - symptoms of systemic or intracranial bleeding, recurrent cerebral and systemic vascular events, and vascular and non-vascular causes of death will be collected. It is estimated that in this trial the absolute risk of death, including fatal haemorrhage, will not differ significantly (ie fall outside the upper 95% CI) from 2% per year on trial drugs versus no trial drugs, when given in addition to guideline drugs; and will not increase bleeding or ischaemic SVD lesions significantly (at the p\<0.01 level) on MRI.

Time frame:
12 months
Reported as:
Count of participants · Participants
Incidence of Treatment Emergent Adverse Effects [Safety]
ParticipantsIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor Cilostazol
Incidence of Treatment Emergent Adverse Effects [Safety]1201
SecondaryTreatment Efficacy - Percentage of Participants Experiencing an Event (Stroke, TIA, Myocardial Ischaemia, Cognitive Impairment and Dementia)

It is estimated that in this trial the combined rate of recurrent stroke, MI, death, cognitive impairment and dependency will be 40-50% at one year after enrolment in order to detect modest but clinically-important reductions in poor outcomes. The study has a 2x2 partial factorial design. This allows testing of both drugs when given alone and together. Participants were allocated into one of four treatment groups. However, as some participants were in a group which received both treatments simultaneously then the subgroups reported for IMP exposure include a count of both participants from the single and the combined treatment groups as the total number exposed to that IMP

Time frame:
12 months
Reported as:
Count of participants · Participants
Treatment Efficacy - Percentage of Participants Experiencing an Event (Stroke, TIA, Myocardial Ischaemia, Cognitive Impairment and Dementia)
ParticipantsIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor Cilostazol
Treatment Efficacy - Percentage of Participants Experiencing an Event (Stroke, TIA, Myocardial Ischaemia, Cognitive Impairment and Dementia)80843655

Adverse events

Collected over From randomisation to 12 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Isosorbide Mononitrate XL (ISMN)1/181 (0.6%)21/181 (11.6%)—
Cilostazol1/182 (0.5%)29/182 (15.9%)—
ISMN XL and Cilostazol0/91 (0%)15/91 (16.5%)—
Neither ISMN Nor Cilostazol1/91 (1.1%)12/91 (13.2%)—
Most frequent serious events
Most frequent serious events
EventIsosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor Cilostazol
GastrointestinalGastrointestinal disorders7/1818/1825/911/91
OtherGeneral disorders5/1816/1823/914/91
CardiovascularCardiac disorders5/1817/1824/912/91
GenitourinaryRenal and urinary disorders1/1814/1821/911/91
Infection/sepsisInfections and infestations2/1814/1822/911/91
Tumour/ malignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1814/1821/911/91
RespiratoryRespiratory, thoracic and mediastinal disorders1/1812/1821/911/91
HaematologicalBlood and lymphatic system disorders1/1810/1820/911/91
MusculoskeletalMusculoskeletal and connective tissue disorders1/1811/1820/910/91
Metabolic/EndocrineMetabolism and nutrition disorders0/1810/1820/910/91

Baseline characteristics

Age, Continuous
Age, Continuous(years)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Median65 (56 to 72)64 (57 to 73)63 (56 to 72)64 (57 to 74)64 (56 to 72)
Sex: Female, Male
Sex: Female, Male(Participants)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Female27282730112
Male63636461251
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Count of participants————0
Stroke onset to randomisation, days
Stroke onset to randomisation, days(days)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Mean223.8 ± 409.8217.8 ± 456.7263.9 ± 614.7192.9 ± 270.3224.6 ± 453.8
Stroke onset to randomisation <=100 days
Stroke onset to randomisation <=100 days(Participants)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Count of participants54534653206
Highest education level - postgraduate
Highest education level - postgraduate(Participants)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Count of participants5610627
Highest education level - undergraduate
Highest education level - undergraduate(Participants)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Count of participants8991137
Highest education level - A Level or Equivalent
Highest education level - A Level or Equivalent(Participants)Isosorbide Mononitrate XL (ISMN)CilostazolISMN XL and CilostazolNeither ISMN Nor CilostazolTotal
Count of participants814141854

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Royal Infirmary
    Edinburgh, Lothian EH16 4SA, United Kingdom
09

References and documents

Publications

  • Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2. PubMed 35833913 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in May 2022, 52 months.

Results were first posted in Nov 2024, 2 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2017
First posted
Mar 2, 2018
StartActual
Jan 8, 2018
Primary completionActual
May 31, 2022
CompletionActual
Aug 11, 2022
Results first posted
Nov 12, 2024
Last update
Nov 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03451591
Lead sponsor
University of Edinburgh
Collaborators
British Heart Foundation, University of Nottingham
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jan 8, 2018
Primary completion
May 31, 2022
Completion
Aug 11, 2022
Results posted
Nov 12, 2024
Last update
Nov 12, 2024

Study contacts

Joanna M Wardlaw, MB ChB
study director · University of Edinburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Isosorbide mononitrate · Cilostazol

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Stroke, Lacunar →

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University of Edinburgh →

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