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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Administered as specified in the treatment arm
CHU Caen
Caen, Normandy, France
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.
Time frame: 22 to 36 hours after treatment
Extracranial hemorrhagic events
Rate of extracranial hemorrhagic events
Time frame: 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.
Time frame: 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)
Time frame: 3 months after treatment
Early neurological improvement
Rate of early neurological improvement defined as an improvement of \>4 NIHSS points 24 hours after treatment.
Time frame: 24 hours after treatment
Plasma VWF multimers
Mean size of VWF multimers before and after treatment
Time frame: Before, at 3 hours and at 24 hours after treatment
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