Use of Hydrogen Sulphide Donor (N-acetyl Cysteine) in Cases With Acute Ischemic Stroke

NCT07749287 | Completed Phase 3 DMC

• 1 other identifier: MS-293-2020
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Clarify novel systemic and local inflammatory mechanisms underlying the cross talk between brain and heart ischemic states,
2. 2.Investigate the new aspects of NAC beyond traditional therapy, in cerebral and myocardial ischemic conditions, both in animal models and clinical cases.

Conditions

Ischemic Cerebral Infarction

Keywords

acute ischemic stroke,; ischemic heart disease,

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  At admission (on day 1) and after 3 days (on day 4).

Study Arms (4)

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).

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.

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).

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.

Drug: N Acetyl cysteine 600mg

Interventions

N Acetyl cysteine 600mg DRUG

* 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).

Group II (AIS-IHD-NAC); Group IV (AIS-NON-IHD-NAC)

Normal (0.9%) saline DRUG

50 ml normal saline was administered either through direct oral route or through nasogastric tube in Ryle feeding patients.

Group I (AIS-IHD); Group III (AIS-NON-IHD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age below 18 years
• Cerebral haemorrhage
• Dural sinus thrombosis
• Glasgow coma scale (GCS) \< 8
• Patients received thrombolytic
• Post arrest

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Stroke Unit, Neurology Department, Kasr Al Ainy, Cairo University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke; Myocardial Ischemia

Interventions

Acetylcysteine; Sodium Chloride

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Lab Technicians
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer Master Degree

Model Details: * 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 6, 2026
• Study Start: June 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)