Ischemic Cerebral InfarctionPhase 3NAC - H2SNCT07749287
Use of Hydrogen Sulphide Donor (N-acetyl Cysteine) in Cases With Acute Ischemic Stroke
A Phase 3 study testing N Acetyl cysteine 600mg and Normal (0.9%) saline in people with Ischemic Cerebral Infarction, run by Helwan University at 1 site in Egypt.
Trial summary
1. Clarify novel systemic and local inflammatory mechanisms underlying the cross talk between brain and heart ischemic states, 2. Investigate the new aspects of NAC beyond traditional therapy, in cerebral and myocardial ischemic conditions, both in animal models and clinical cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cerebral Infarction
- What is being tested?
- N Acetyl cysteine 600mg and Normal (0.9%) saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- AIS patients admitted into stroke unit
- Onset within 48 hours
- Glasgow coma scale (GCS) ≥ 8
- Out of window or contraindicated for thrombolytics
- Not arrested before
Who cannot join
- Age below 18 years
- Cerebral haemorrhage
- Dural sinus thrombosis
- Glasgow coma scale (GCS) < 8
- Patients received thrombolytic
- Post arrest
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Stroke Unit, Neurology Department, Kasr Al Ainy, Cairo University Hospital
Cairo
About this study
Official title: Assessment of Therapeutic Role of H2S Donor in Acute Myocardial Infarction and Acute Cerebral Ischemia: Comparison in Animal Models and Clinical Cases.
- Clarify novel systemic and local inflammatory mechanisms underlying the cross talk between brain and heart ischemic states,
- Investigate the new aspects of NAC beyond traditional therapy, in cerebral and myocardial ischemic conditions, both in animal models and clinical cases.
Read the detailed description
The study was conducted on 121 adult acute ischemic stroke patients admitted to stroke unit; either intermediate care or intensive care, of Kasr El Ainy Medical Hospital, Cairo University. Five patients were excluded as they didn't meet our eligibility criteria.
Oral form of NAC was given. Patients were divided into 4 groups:
- Group I (AIS-IHD): critically ill AIS patients who had past history and / or current evidence of IHD (30 patients), Without administration of NAC (as a control group).
- Group II (AIS-IHD-NAC): critically ill AIS patients who had past history and / or current evidence of ischemic heart disease (IHD) (30 patients), With nasogastric or oral administration of NAC.
- Group III (AIS-NON-IHD): critically ill AIS patients who had Neither past history Nor current evidence of IHD (27 patients), Without administration of NAC (as a control group).
- Group IV (AIS-NON-IHD-NAC): critically ill AIS patients who had Neither past history Nor current evidence of IHD (29 patients), With nasogastric or oral administration of NAC.
- Conditions
- Ischemic Cerebral Infarction
- Being tested
- N Acetyl cysteine 600mg, Normal (0.9%) saline
- Keywords
- acute ischemic stroke,, ischemic heart disease,
- Medical subject headings
- Ischemic Stroke, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N Acetyl cysteine 600mgDrug
- NAC was administered in a dose of 600 mg, every 8 hours, for 3 consecutive days, either through direct oral route, or indirectly through Ryle tube (in Ryle-feeding patients).
- NAC was started shortly after hospital admission, following baseline assessment of patient.
- NAC sachet form was used, so it was administrated as liquid oral solution, which was prepared from pure NAC powder, dissolved in water.
- This recommended dose is within the approved therapeutic range (World Health Organization, 2021).
Normal (0.9%) salineDrug
50 ml normal saline was administered either through direct oral route or through nasogastric tube in Ryle feeding patients.
| Study group | Role | What they receive |
|---|---|---|
| Group I (AIS-IHD) | Placebo comparator | critically ill AIS patients who had past history and / or current evidence of IHD (30 patients), With oral saline administration (as a control group). Receives: Drug: Normal (0.9%) saline |
| Group II (AIS-IHD-NAC) | Active comparator | critically ill AIS patients who had past history and / or current evidence of ischemic heart disease (IHD) (30 patients), With nasogastric or oral administration of NAC. Receives: Drug: N Acetyl cysteine 600mg |
| Group III (AIS-NON-IHD) | Placebo comparator | critically ill AIS patients who had Neither past history Nor current evidence of IHD (27 patients), With oral saline administration (as a control group). Receives: Drug: Normal (0.9%) saline |
| Group IV (AIS-NON-IHD-NAC) | Active comparator | critically ill AIS patients who had Neither past history Nor current evidence of IHD (29 patients), With nasogastric or oral administration of NAC. Receives: Drug: N Acetyl cysteine 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the functional outcome.
This outcome was assessed by evaluation of Glasgow Coma Score, the minimum and the worst = 3, and the maximum and the best = 15. It depends on assessment of Eye opening, Verbal response, Motor response.
Also, evaluation of Modified Rankin Scale, for measuring the degree of disability following stroke, the maximum and the worst = 6, the minimum and the best = 0.
Furthermore, evaluation of National Institutes of Health Stroke Scale (NIHSS), the most widely used functional assessment score for stroke, the maximum and the worst = 42, and the minimum and the best = 0. It depends on assessment of various clinical aspects, e.g., consciousness, orientation, vision, gaze, fascial palsy, speech, motor power, coordination, and sensation.
Measured: At admission (on day 1), after 3 days (on day 4), and at discharge from hospital (up to day 30).
Secondary outcomes (1)
Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the inflammatory storm and autophagy markers.
Inflammatory storm and autophagy markers were evaluated by measuring serum levels of C-Reactive Protein, Total Leucocytic Count, and LC3B, BECN1, respectively.
Measured: At admission (on day 1) and after 3 days (on day 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jun 2021
- Primary completion1 Jan 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * NAC was administered shortly after hospital admission, in a dose of 600 mg, every 8 hours, for 3 consecutive days, either through direct oral route, or indirectly through Ryle tube (in Ryle-feeding patients). * NAC sachet form was administrated as liquid oral solution, prepared from pure NAC powder, dissolved in water. This recommended dose is within the approved therapeutic range. * Clinical functional assessment of stroke patients was done on admission, on day 4, and before discharge, by Glasgow Coma Score, Modified Rankin Scale, and National Institutes of Health Stroke Scale. * Biochemical assessment of stroke patients was done on admission, and on day 4, by C-reactive protein, total leucocytic count, and autophagy markers (LC3B and BECN1). * Length of stay in hospital was calculated by means of total number of days between date of admission and date of discharge. * Clinical outcome (mortality and morbidity) was assessed at discharge to all patients.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mousad, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749287
- Sponsor's protocol ID
- MS-293-2020
- Acronym
- NAC - H2S
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: because these results are not published yet
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Therapeutic Role of H2S Donor in Acute Myocardial Infarction and Acute Cerebral Ischemia: Comparison in Animal Models and Clinical Cases.
- ClinicalTrials.gov ID
- NCT07749287
- Acronym / sponsor ID
- NAC - H2S / MS-293-2020
- Conditions
- Ischemic Cerebral Infarction
- Keywords
- acute ischemic stroke,, ischemic heart disease,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Clarify novel systemic and local inflammatory mechanisms underlying the cross talk between brain and heart ischemic states,
- Investigate the new aspects of NAC beyond traditional therapy, in cerebral and myocardial ischemic conditions, both in animal models and clinical cases.
Detailed description
The study was conducted on 121 adult acute ischemic stroke patients admitted to stroke unit; either intermediate care or intensive care, of Kasr El Ainy Medical Hospital, Cairo University. Five patients were excluded as they didn't meet our eligibility criteria.
Oral form of NAC was given. Patients were divided into 4 groups:
- Group I (AIS-IHD): critically ill AIS patients who had past history and / or current evidence of IHD (30 patients), Without administration of NAC (as a control group).
- Group II (AIS-IHD-NAC): critically ill AIS patients who had past history and / or current evidence of ischemic heart disease (IHD) (30 patients), With nasogastric or oral administration of NAC.
- Group III (AIS-NON-IHD): critically ill AIS patients who had Neither past history Nor current evidence of IHD (27 patients), Without administration of NAC (as a control group).
- Group IV (AIS-NON-IHD-NAC): critically ill AIS patients who had Neither past history Nor current evidence of IHD (29 patients), With nasogastric or oral administration of NAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- * NAC was administered shortly after hospital admission, in a dose of 600 mg, every 8 hours, for 3 consecutive days, either through direct oral route, or indirectly through Ryle tube (in Ryle-feeding patients). * NAC sachet form was administrated as liquid oral solution, prepared from pure NAC powder, dissolved in water. This recommended dose is within the approved therapeutic range. * Clinical functional assessment of stroke patients was done on admission, on day 4, and before discharge, by Glasgow Coma Score, Modified Rankin Scale, and National Institutes of Health Stroke Scale. * Biochemical assessment of stroke patients was done on admission, and on day 4, by C-reactive protein, total leucocytic count, and autophagy markers (LC3B and BECN1). * Length of stay in hospital was calculated by means of total number of days between date of admission and date of discharge. * Clinical outcome (mortality and morbidity) was assessed at discharge to all patients.
| Arm | Type | Receives |
|---|---|---|
| Group I (AIS-IHD) | Placebo comparator | Drug: Normal (0.9%) salinecritically ill AIS patients who had past history and / or current evidence of IHD (30 patients), With oral saline administration (as a control group). |
| Group II (AIS-IHD-NAC) | Active comparator | Drug: N Acetyl cysteine 600mgcritically ill AIS patients who had past history and / or current evidence of ischemic heart disease (IHD) (30 patients), With nasogastric or oral administration of NAC. |
| Group III (AIS-NON-IHD) | Placebo comparator | Drug: Normal (0.9%) salinecritically ill AIS patients who had Neither past history Nor current evidence of IHD (27 patients), With oral saline administration (as a control group). |
| Group IV (AIS-NON-IHD-NAC) | Active comparator | Drug: N Acetyl cysteine 600mgcritically ill AIS patients who had Neither past history Nor current evidence of IHD (29 patients), With nasogastric or oral administration of NAC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years
- AIS patients admitted into stroke unit
- Onset within 48 hours
- Glasgow coma scale (GCS) ≥ 8
- Out of window or contraindicated for thrombolytics
Key exclusion criteria (6 listed)
- Age below 18 years
- Cerebral haemorrhage
- Dural sinus thrombosis
- Glasgow coma scale (GCS) < 8
- Patients received thrombolytic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N Acetyl cysteine 600mg* NAC was administered in a dose of 600 mg, every 8 hours, for 3 consecutive days, either through direct oral route, or indirectly through Ryle tube (in Ryle-feeding patients). * NAC was started shortly after hospital admission, following baseline assessment of patient. * NAC sachet form was used, so it was administrated as liquid oral solution, which was prepared from pure NAC powder, dissolved in water. * This recommended dose is within the approved therapeutic range (World Health Organization, 2021). | Drug | Group II (AIS-IHD-NAC), Group IV (AIS-NON-IHD-NAC) |
| Normal (0.9%) saline50 ml normal saline was administered either through direct oral route or through nasogastric tube in Ryle feeding patients. | Drug | Group I (AIS-IHD), Group III (AIS-NON-IHD) |
Primary outcome
Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the functional outcome.
Time frame: At admission (on day 1), after 3 days (on day 4), and at discharge from hospital (up to day 30).
This outcome was assessed by evaluation of Glasgow Coma Score, the minimum and the worst = 3, and the maximum and the best = 15. It depends on assessment of Eye opening, Verbal response, Motor response. Also, evaluation of Modified Rankin Scale, for measuring the degree of disability following stroke, the maximum and the worst = 6, the minimum and the best = 0. Furthermore, evaluation of National Institutes of Health Stroke Scale (NIHSS), the most widely used functional assessment score for stroke, the maximum and the worst = 42, and the minimum and the best = 0. It depends on assessment of various clinical aspects, e.g., consciousness, orientation, vision, gaze, fascial palsy, speech, motor power, coordination, and sensation.
1 secondary outcome
Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the inflammatory storm and autophagy markers.
Time frame: At admission (on day 1) and after 3 days (on day 4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. because these results are not published yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N Acetyl cysteine 600mg and Normal (0.9%) saline in people with Ischemic Cerebral Infarction, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the functional outcome. (time frame: At admission (on day 1), after 3 days (on day 4), and at discharge from hospital (up to day 30).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.