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Completed

NCT Number: NCT07749287

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

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.

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Key information

Conditions

Ischemic Cerebral Infarction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Stroke Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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).

Normal (0.9%) saline

Drug

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

Primary outcomes

  1. 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.

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.

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

    Inflammatory storm and autophagy markers were evaluated by measuring serum levels of C-Reactive Protein, Total Leucocytic Count, and LC3B, BECN1, respectively.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

Assessment of Therapeutic Role of H2S Donor in Acute Myocardial Infarction and Acute Cerebral Ischemia: Comparison in Animal Models and Clinical Cases.

Acronym: NAC - H2S

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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