Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)
NCT07252544, Phase 3, Not yet recruiting, Beijing Tiantan Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT) | ClinicalTrials.gov |
| NCT number | NCT07252544 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 3,156 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Tiantan Hospital | ClinicalTrials.gov |
| Conditions | Stroke, Lacunar, Stroke, Acute Ischemic, Cerebral Small Vessel Diseases | ClinicalTrials.gov |
| Interventions | Isosorbide Mononitrate, Butylphthalide, Isosorbide Mononitrate Placebo, Butylphthalide Placebo | ClinicalTrials.gov |
| First posted | 2025-11-26 | ClinicalTrials.gov |
| Last updated | 2025-11-26 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants with post-stroke disability at 6 months | 6 months | A composite endpoint defined as the occurrence of any of the following: modified Rankin Scale (mRS) score ≥ 3, major adverse cardiovascular events (MACE), cognitive impairment, or all-cause mortality. The mRS measures post-stroke functional outcome on a scale from 0 (no symptoms) to 6 (death). MACE includes non-fatal stroke, non-fatal myocardial infarction (MI), and vascular death.The assessment of cognitive function involves three stages: a cognitive screening test, supplementary cognitive testing, and adjudication by an expert panel. The Beijing version of the Montreal Cognitive Assessment (MoCA) is used as the cognitive screening scale. Scores on the MoCA range from 0 to 30, with lower scores indicating greater cognitive impairment.The supplementary cognitive assessment includes the evaluation of several domains: executive function, attention and processing speed, language, and memory, as well as activities of daily living. | ClinicalTrials.gov |
| Primary | Incidence of moderate or more severe headache within 6 months | 6 months | Headache severity is assessed using the Numerical Rating Scale (NRS), where: 0 indicates no pain; 1 represents a mild headache (including feelings of head pressure or throbbing that are not considered painful); a score of 4 or higher (≥4) represents a headache of at least moderate intensity; and 10 represents the worst headache imaginable to the subject. | ClinicalTrials.gov |
| Secondary | Proportion of participants with post-stroke disability at 1 year | 1 year | The difinition of post-stroke disability is the same as the primary outcome measure. | ClinicalTrials.gov |
| Secondary | Proportion of participants with the modified Rankin Scale (mRS) score ≥ 3 at 6 months and 1 year | 6 months and 1 year | The modified Rankin Scale (mRS) is used to measure the degree of disability and dependence after a stroke. The scale ranges from 0 to 6. A score of 0 represents no symptoms, 1 represents no significant disability, 2 represents slight disability, 3 represents moderate disability, 4 represents moderately severe disability, 5 represents severe disability, and 6 represents death. | ClinicalTrials.gov |
| Secondary | Incidence of recurrent stroke within 6 months and 1 year | 6 months and 1 year | ClinicalTrials.gov | |
| Secondary | Proportion of participants with dementia at 6 months and 1 year | 6 months and 1 year | Dementia (all of the following criteria must be met): A. Evidence of significant cognitive decline from a previous level of performance in one or more cognitive domains (complex attention, executive function, learning and memory, language, perceptual-motor, or social cognition) based on:1.Concern from the individual, a knowledgeable informant, or the clinician that there has been a significant decline in cognitive function. 2.A substantial impairment in cognitive performance, preferably documented by standardized neuropsychological testing or, in its absence, another quantified clinical assessment. B. The cognitive deficits interfere with independence in everyday activities (i.e., at a minimum, requiring assistance with complex instrumental activities of daily living, such as paying bills or managing medications). C. The cognitive deficits do not occur exclusively in the context of a delirium. D. The cognitive deficits are not better explained by another mental disorder. | ClinicalTrials.gov |
| Secondary | National Institutes of Health Stroke Scale (NIHSS) scores at 7 days, 6 months, and 1 year (including changes from baseline) | baseline, 7 days, 6 months, and 1 year | The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to objectively measure the severity of a stroke by quantifying a patient's neurological deficits. Its primary purposes are to evaluate the acuity of a stroke, guide treatment decisions, and predict patient outcomes. The scale's total score ranges from 0 to 42, with higher scores representing more severe neurological impairment. | ClinicalTrials.gov |
| Secondary | Incidence of hypotension within 6 months | 6 months | Hypotension is defined as a systolic blood pressure (SBP) of less than 100 mmHg or a 30% decrease from baseline. | ClinicalTrials.gov |
| Secondary | Incidence of syncope within 6 months | 6 months | Syncope is a transient loss of consciousness caused by transient global cerebral hypoperfusion, characterized by a rapid onset, short duration, and spontaneous, complete recovery. The diagnosis requires the following conditions to be met: 1. A transient loss of consciousness with a rapid onset (from a few seconds to 1 minute); 2. A short duration (from a few seconds to a few minutes); 3. Spontaneous and complete recovery; 4. Absence of focal neurological signs; 5. Exclusion of head trauma and epileptic seizures. | ClinicalTrials.gov |
| Secondary | Incidence of liver function impairment within 6 months | 6 months | Liver function impairment may be diagnosed if at least one of the following criteria is met: 1. Serum AST or ALT \> 5 × the upper limit of normal (ULN), or ALP \> 2 × ULN (or from an abnormal baseline value); 2. Serum total bilirubin (TBil) \> 2.5 mg/dL (42.75 μmol/L) accompanied by any elevation in serum AST, ALT, or ALP levels. | ClinicalTrials.gov |
| Secondary | Incidence of any bleeding within 6 months | 6 months | Bleeding events are evaluated using the GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) classification and categorized as severe, moderate, or mild. | ClinicalTrials.gov |
| Secondary | Incidence of symptomatic intracranial hemorrhage within 6 months | 6 months | According to the Heidelberg Bleeding Classification established at the 12th Thrombolytic Therapy in Acute Ischemic Stroke workshop in Germany in 2015, symptomatic intracerebral hemorrhage (sICH) is defined as meeting all of the following conditions: 1. Any form of intracranial hemorrhage (including types 1a, 1b, 1c, 2, 3a, 3b, 3c, and 3d of the Heidelberg classification) that is detected by imaging (head CT or MRI) and confirmed by a radiologist; 2. The patient experiences clinical deterioration, defined as: an increase in the NIHSS score of ≥ 4 points from the last score prior to deterioration, OR an increase of ≥ 2 points on any single item of the NIHSS, OR an outcome leading to tracheal intubation, decompressive craniectomy, ventricular drainage, or other major medical/surgical intervention; 3. The clinical deterioration cannot be explained by any cause other than the intracranial hemorrhage. | ClinicalTrials.gov |
| Other | ≥ 80% of patients taking ≥ 50% of the trial dose up to 6 months | 6 months | ClinicalTrials.gov | |
| Other | Concentration of blood biomarkers predictive of drug efficacy at 6 months and 1 year | baseline, 6 months and 1 year | Changes in the levels of neuroinflammation indicators, thormbotic inflammation indicators and novel blood-based biomarkers \[e.g. phosphodiesterase 3A(PDE3A), transgelin 2(TAGLN2), integrin subunit alpha M(ITGAM), protein phosphatase, Mg2+/Mn2+ dependent 1D(PPM1D)\] associated with the prognosis of CSVD compared with baseline levels at 6 months and 1 year. | ClinicalTrials.gov |
| Other | Changes in white matter integrity at 6 months and 1 year | baseline, 6 months and 1 year | Assessed using Diffusion Tensor Imaging (DTI) with fiber tractography to evaluate the structural integrity of white matter fibre tract. | ClinicalTrials.gov |
| Other | Changes in functional connectivity networks at 6 months and 1 year | baseline, 6 months and 1 year | Assessed using resting-state functional MRI (rs-fMRI) to measure the temporal correlation and connectivity between brain regions within a specific network. | ClinicalTrials.gov |
| Other | Changes in neurovascular coupling (imaging biomarker) at 6 months and 1 year | baseline, 6 months and 1 year | Assessed by combining Arterial Spin Labeling (ASL) and Blood-Oxygen-Level-Dependent (BOLD) fMRI to measure the hemodynamic response following neural activity in specific regions. | ClinicalTrials.gov |
| Other | Changes in glymphatic function at 6 months and 1 year | baseline, 6 months and 1 year | Assessed using two complementary methods: the Diffusion Tensor Image Analysis Along the Perivascular Space (DTI-ALPS) index, which serves as an imaging proxy for glymphatic system activity, and the quantification of Basal Ganglia Enlarged Perivascular Spaces (BG-EPVS) volume from high-resolution 3D T2-weighted images. | ClinicalTrials.gov |
| Other | Changes in brain tissue free water at 6 months and 1 year | baseline, 6 months and 1 year | Assessed using multi-compartment Diffusion Tensor Imaging (DTI) models to quantify the fraction of extracellular free water, considered a marker for neuroinflammation and edema. | ClinicalTrials.gov |
| Other | Changes in heart rate variability (HRV) at 6 months and 1 year | baseline, 6 months and 1 year | Assessed via analysis of Electrocardiogram (ECG) recordings to evaluate the balance of the autonomic nervous system. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
| Verbal Learning | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)