N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE

Trial details

Who runs it

University Hospital, Caen

Trial code

NCT04920448

Record updated

2025. július 25.

Original description

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 full original descriptionShow less

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.

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

ClinicalTrials.gov NCT04920448