Trial · NCT03451591
LACunar Intervention (LACI-2) Trial-2
NCT03451591, Phase 2, Phase 3, Completed, University of Edinburgh; results first posted 2024-11-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LACunar Intervention (LACI-2) Trial-2. Trials, record NCT03451591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03451591
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LACunar Intervention (LACI-2) Trial-2
- NCT number
- NCT03451591
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 363 participants, actual
- Lead sponsor
- University of Edinburgh
- Conditions
- Cerebral Small Vessel Diseases, Stroke, Lacunar
- Interventions
- Isosorbide Mononitrate XL (ISMN), Cilostazol, ISMN XL and Cilostazol, Neither ISMN nor cilostazol
- First posted
- 2018-03-02
- Last updated
- 2024-11-12
- Other registries' IDs
- eudract:2016-002277-35, isrctn:ISRCTN14911850
- Results first posted
- 2024-11-12
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Phase III Trial | 36 months (24 Months Recruitment + 12 months Follow Up) | 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. |
| Secondary | Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year | 12 months | 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). |
| Secondary | Incidence of Treatment Emergent Adverse Effects [Safety] | 12 months | 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. |
| Secondary | Treatment Efficacy - Percentage of Participants Experiencing an Event (Stroke, TIA, Myocardial Ischaemia, Cognitive Impairment and Dementia) | 12 months | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility of Phase III Trial | 36 months (24 Months Recruitment + 12 months Follow Up) | Number of participants at 12 months who did not complete follow up - because they refused, were lost to follow up or withdrawn | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year | 12 months | Adherence to medication at half dose or more at 1 year | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Treatment Emergent Adverse Effects [Safety] | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment Efficacy - Percentage of Participants Experiencing an Event (Stroke, TIA, Myocardial Ischaemia, Cognitive Impairment and Dementia) | 12 months | Clinical, functional, QoL and global outcomes at 12 months- Stroke/TIA, MI, Cognitive impairment, Dependency, Death. Data are number (%) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility of Phase III Trial | Isosorbide Mononitrate XL (ISMN) | 20 | Participants | ||
| Feasibility of Phase III Trial | Cilostazol | 21 | Participants | ||
| Feasibility of Phase III Trial | ISMN XL and Cilostazol | 10 | Participants | ||
| Feasibility of Phase III Trial | Neither ISMN Nor Cilostazol | 4 | Participants | ||
| Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year | Isosorbide Mononitrate XL (ISMN) | 59 | Participants | ||
| Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year | Cilostazol | 48 | Participants | ||
| Trial Medication Tolerability Measured by Number of Participants With Adherence to Medication at Half Dose or More at 1 Year | ISMN XL and Cilostazol | 45 | Participants | ||
| Incidence of Treatment Emergent Adverse Effects [Safety] | Isosorbide Mononitrate XL (ISMN) | 1 | Participants | ||
| Incidence of Treatment Emergent Adverse Effects [Safety] | Cilostazol | 2 | Participants | ||
| Incidence of Treatment Emergent Adverse Effects [Safety] | ISMN XL and Cilostazol | 0 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomisation | STARTED | Isosorbide Mononitrate XL (ISMN) | 90 | |
| Randomisation | STARTED | Cilostazol | 91 | |
| Randomisation | STARTED | ISMN XL and Cilostazol | 91 | |
| Randomisation | STARTED | Neither ISMN Nor Cilostazol | 91 | |
| Randomisation | COMPLETED | Isosorbide Mononitrate XL (ISMN) | 90 | |
| Randomisation | COMPLETED | Cilostazol | 91 | |
| Randomisation | COMPLETED | ISMN XL and Cilostazol | 91 | |
| Randomisation | COMPLETED | Neither ISMN Nor Cilostazol | 91 | |
| Randomisation | NOT COMPLETED | Isosorbide Mononitrate XL (ISMN) | 0 | |
| Randomisation | NOT COMPLETED | Cilostazol | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Respiratory | Respiratory, thoracic and mediastinal disorders | Isosorbide Mononitrate XL (ISMN) | 1 | 181 | 1 |
| serious | Respiratory | Respiratory, thoracic and mediastinal disorders | Cilostazol | 2 | 182 | 2 |
| serious | Respiratory | Respiratory, thoracic and mediastinal disorders | ISMN XL and Cilostazol | 1 | 91 | 1 |
| serious | Respiratory | Respiratory, thoracic and mediastinal disorders | Neither ISMN Nor Cilostazol | 1 | 91 | 1 |
| serious | Gastrointestinal | Gastrointestinal disorders | Isosorbide Mononitrate XL (ISMN) | 7 | 181 | 7 |
| serious | Gastrointestinal | Gastrointestinal disorders | Cilostazol | 8 | 182 | 8 |
| serious | Gastrointestinal | Gastrointestinal disorders | ISMN XL and Cilostazol | 5 | 91 | 5 |
| serious | Gastrointestinal | Gastrointestinal disorders | Neither ISMN Nor Cilostazol | 1 | 91 | 1 |
| serious | Genitourinary | Renal and urinary disorders | Isosorbide Mononitrate XL (ISMN) | 1 | 181 | 1 |
| serious | Genitourinary | Renal and urinary disorders | Cilostazol | 4 | 182 | 4 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Isosorbide Mononitrate XL (ISMN) | 1 | 181 |
| Total, all-cause mortality | Cilostazol | 1 | 182 |
| Total, all-cause mortality | ISMN XL and Cilostazol | 0 | 91 |
| Total, all-cause mortality | Neither ISMN Nor Cilostazol | 1 | 91 |
| Total, other adverse events | Isosorbide Mononitrate XL (ISMN) | 0 | 0 |
| Total, other adverse events | Cilostazol | 0 | 0 |
| Total, other adverse events | ISMN XL and Cilostazol | 0 | 0 |
| Total, other adverse events | Neither ISMN Nor Cilostazol | 0 | 0 |
| Total, serious adverse events | Isosorbide Mononitrate XL (ISMN) | 21 | 181 |
| Total, serious adverse events | Cilostazol | 29 | 182 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03451591
GET https://conductscience.org/api/trials/v1/NCT03451591/flow?page=2