Back to resultsN-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE (NAC-S)
Primary Purpose
Stroke, Ischemic
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
N-Acetyl cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring Thrombolysis, Hemorrhagic transformation, Alteplase, Thrombectomy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- CHU Caen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
N-Acetylcysteine 150 mg/kg
Arm Description
Single intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Extracranial hemorrhagic events
Rate of extracranial hemorrhagic events
Treatment related side effects
Rate of any drug related side effects according to the Common Terminology Criteria of Adverse Event 5.0.
Mortality and functional independence
Rate of mortality and functional independence at 3 months according to the modified Rankin scale (mRs)
Early neurological improvement
Rate of early neurological improvement defined as an improvement of >4 NIHSS points 24 hours after treatment.
Plasma VWF multimers
Mean size of VWF multimers before and after treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04920448
Brief Title
N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE
Acronym
NAC-S
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 7, 2021 (Anticipated)
Primary Completion Date
June 8, 2022 (Anticipated)
Study Completion Date
September 7, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Thrombolysis, Hemorrhagic transformation, Alteplase, Thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N-Acetylcysteine 150 mg/kg
Arm Type
Experimental
Arm Description
Single intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes).
Intervention Type
Drug
Intervention Name(s)
N-Acetyl cysteine
Other Intervention Name(s)
HIDONAC
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Symptomatic intracranial hemorrhagic transformation
Description
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.
Time Frame
22 to 36 hours after treatment
Secondary Outcome Measure Information:
Title
Extracranial hemorrhagic events
Description
Rate of extracranial hemorrhagic events
Time Frame
Up to 3 months after treatment
Title
Treatment related side effects
Description
Rate of any drug related side effects according to the Common Terminology Criteria of Adverse Event 5.0.
Time Frame
Up to 3 months after treatment
Title
Mortality and functional independence
Description
Rate of mortality and functional independence at 3 months according to the modified Rankin scale (mRs)
Time Frame
3 months after treatment
Title
Early neurological improvement
Description
Rate of early neurological improvement defined as an improvement of >4 NIHSS points 24 hours after treatment.
Time Frame
24 hours after treatment
Title
Plasma VWF multimers
Description
Mean size of VWF multimers before and after treatment
Time Frame
Before, at 3 hours and at 24 hours after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Boulanger, MD, PhD
Phone
+33231064617
Email
boulanger-ma@chu-caen.fr
Facility Information:
Facility Name
CHU Caen
City
Caen
State/Province
Normandy
ZIP/Postal Code
14000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Boulanger, MD, PhD
Phone
+33231064617
Email
boulanger-ma@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel TOUZE, MD, PhD
Phone
+33231064617
Email
touze-e@chu-caen.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
28487393
Citation
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.
Results Reference
background
Learn more about this trial
N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE
We'll reach out to this number within 24 hrs