Status:
TERMINATED
N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE
Lead Sponsor:
University Hospital, Caen
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18-86 years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04920448
Start Date
June 16 2021
End Date
April 25 2024
Last Update
July 25 2025
Active Locations (1)
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1
CHU Caen
Caen, Normandy, France, 14000