NCT04920448

Brief Summary

The primary objective of the study is to assess the safety of N-Acetylcysteine as a thrombolytic agent in acute ischemic stroke, especially regarding the risk of hemorrhagic transformation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

June 3, 2021

Last Update Submit

July 22, 2025

Conditions

Stroke, Ischemic

Keywords

ThrombolysisHemorrhagic transformationAlteplaseThrombectomy

Outcome Measures

Primary Outcomes (1)

  • Symptomatic intracranial hemorrhagic transformation

    Rate of symptomatic hemorrhagic transformation according to the SITS-MOST criteria: a local or remote parenchymal hemorrhage on imaging 22 to 36 hours after treatment or earlier if the imaging scan was performed due to clinical deterioration combined with a neurological deterioration of \>4 NIHSS points from baseline or from the lowest NIHSS score between baseline and 24 hours or leading to death within 24 hours.

    22 to 36 hours after treatment

Secondary Outcomes (5)

  • Extracranial hemorrhagic events

    Up to 3 months after treatment

  • Treatment related side effects

    Up to 3 months after treatment

  • Mortality and functional independence

    3 months after treatment

  • Early neurological improvement

    24 hours after treatment

  • Plasma VWF multimers

    Before, at 3 hours and at 24 hours after treatment

Study Arms (1)

N-Acetylcysteine 150 mg/kg

EXPERIMENTAL

Single intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes).

Drug: N-Acetyl cysteine

Interventions

N-Acetyl cysteineDRUG

Administered as specified in the treatment arm

Also known as: HIDONAC
N-Acetylcysteine 150 mg/kg

Eligibility Criteria

Age18 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient presenting with an acute ischemic stroke (non lacunar) as assessed by cerebral imaging (either CT or MRI), with or without visible vessel occlusion.
  • Patient eligible to intravenous thrombolysis according to current criteria, including patients who will also benefit from endovascular treatment (if eligible).
  • Personal or familial consent to participate in the study.

You may not qualify if:

  • Known hypersensitivity to N-Acetylcysteine or to any excipient from the formulation.
  • Coma and/or NIHSS \<4 or ≥20.
  • Known asthma or chronic obstructive pulmonary disease requiring bronchodilatators or steroids.
  • Participation to another interventional study if it requires administration of an experimental treatment in the first 3 days after NAC treatment.
  • Women of childbearing age (age \< or = to 50)
  • Known history of prior treatment with vitamin-K antagonist or direct oral anticoagulant.
  • Known history of severe hepatopathy including cirrhosis, portal hypertension (esophageal varices) and evolutive hepatopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen

Caen, Normandy, 14000, France

Location

Related Publications (1)

  • Martinez de Lizarrondo S, Gakuba C, Herbig BA, Repesse Y, Ali C, Denis CV, Lenting PJ, Touze E, Diamond SL, Vivien D, Gauberti M. Potent Thrombolytic Effect of N-Acetylcysteine on Arterial Thrombi. Circulation. 2017 Aug 15;136(7):646-660. doi: 10.1161/CIRCULATIONAHA.117.027290. Epub 2017 May 9.

    PMID: 28487393BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 9, 2021

Study Start

June 16, 2021

Primary Completion

April 25, 2023

Study Completion

April 25, 2024

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

FR(1)