N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE

• Status: Not yet recruiting
• Trial end date: 2022-09-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Treatments: Acetylcysteine; N-monoacetylcystine

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.