Stroke, IschemicPhase 2NAC-SNCT04920448
N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE
A Phase 2 study testing N-Acetyl cysteine in people with Stroke, Ischemic, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- N-Acetyl cysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2021to 25 Apr 2024
- Phase
- Phase 2
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known hypersensitivity to N-Acetylcysteine or to any excipient from the formulation.
- Coma and/or NIHSS <4 or ≥20.
- Daily treatment with Nitrovasodilator before the inclusion.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TOLERANCE STUDY OF N-ACETYLCYSTEINE FOR THROMBOLYSIS IN THE ACUTE PHASE OF ISCHEMIC STROKE / ETUDE DE TOLERANCE DE LA N-ACETYLCYSTEINE POUR LA THROMBOLYSE A LA PHASE AIGUË DE L'INFARCTUS CEREBRAL
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.
Read the detailed description
Preclinical studies demonstrated that N-Acetylcysteine (NAC) is able to break von Willebrand Factor (VWF) multimers by bisulfide bond reduction. Since thrombi in stroke patients are rich in VWF, NAC could be used as a thrombolytic agent during the acute phase. This study aims at assessing the safety of NAC in combination with alteplase (rt-PA) at the acute phase of ischemic stroke.
- Conditions
- Stroke, Ischemic
- Being tested
- N-Acetyl cysteine
- Keywords
- Thrombolysis, Hemorrhagic transformation, Alteplase, Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl cysteineDrug
Also called HIDONAC
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| N-Acetylcysteine 150 mg/kg | Experimental | Single intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes). Receives: Drug: N-Acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 to 36 hours after treatment
Secondary outcomes (5)
Extracranial hemorrhagic events
Rate of extracranial hemorrhagic events
Measured: Up to 3 months after treatment
Treatment related side effects
Rate of any drug related side effects according to the Common Terminology Criteria of Adverse Event 5.0.
Measured: Up to 3 months after treatment
Mortality and functional independence
Rate of mortality and functional independence at 3 months according to the modified Rankin scale (mRs)
Measured: 3 months after treatment
Early neurological improvement
Rate of early neurological improvement defined as an improvement of >4 NIHSS points 24 hours after treatment.
Measured: 24 hours after treatment
Plasma VWF multimers
Mean size of VWF multimers before and after treatment
Measured: Before, at 3 hours and at 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start16 Jun 2021
- Primary completion25 Apr 2023
- Study completion25 Apr 2024
Why it stopped: lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920448
- Sponsor's protocol ID
- 20-079
- Acronym
- NAC-S
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28487393
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOLERANCE STUDY OF N-ACETYLCYSTEINE FOR THROMBOLYSIS IN THE ACUTE PHASE OF ISCHEMIC STROKE / ETUDE DE TOLERANCE DE LA N-ACETYLCYSTEINE POUR LA THROMBOLYSE A LA PHASE AIGUË DE L'INFARCTUS CEREBRAL
- ClinicalTrials.gov ID
- NCT04920448
- Acronym / sponsor ID
- NAC-S / 20-079
- Conditions
- Stroke, Ischemic
- Keywords
- Thrombolysis, Hemorrhagic transformation, Alteplase, Thrombectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patients
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 9 Jun 2021 (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.
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.
Detailed description
Preclinical studies demonstrated that N-Acetylcysteine (NAC) is able to break von Willebrand Factor (VWF) multimers by bisulfide bond reduction. Since thrombi in stroke patients are rich in VWF, NAC could be used as a thrombolytic agent during the acute phase. This study aims at assessing the safety of NAC in combination with alteplase (rt-PA) at the acute phase of ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-Acetylcysteine 150 mg/kg | Experimental | Drug: N-Acetyl cysteineSingle intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes). |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Known hypersensitivity to N-Acetylcysteine or to any excipient from the formulation.
- Coma and/or NIHSS <4 or ≥20.
- Daily treatment with Nitrovasodilator before the inclusion.
- 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.
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 cysteineAlso: HIDONACAdministered as specified in the treatment arm | Drug | N-Acetylcysteine 150 mg/kg |
Primary outcome
Symptomatic intracranial hemorrhagic transformation
Time frame: 22 to 36 hours after treatment
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.
5 secondary outcomes
Extracranial hemorrhagic events
Time frame: Up to 3 months after treatment
Treatment related side effects
Time frame: Up to 3 months after treatment
Mortality and functional independence
Time frame: 3 months after treatment
Early neurological improvement
Time frame: 24 hours after treatment
Plasma VWF multimers
Time frame: Before, at 3 hours and at 24 hours after treatment
Results and safety
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 28487393Martinez 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.
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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 2 study testing N-Acetyl cysteine in people with Stroke, Ischemic, run by University Hospital, Caen at 1 site in France.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Jul 2025. 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 France. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: lack of patients). Results are not available in the source record.
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?
Symptomatic intracranial hemorrhagic transformation (time frame: 22 to 36 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04920448, which also lists 1 linked publication.
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 25 Jul 2025.