N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE (NAC-S)

Caen University Hospital

Status and phase: Unknown; Phase 2

Conditions: Stroke, Ischemic

Treatments: Drug: N-Acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04920448

20-079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18 to 86 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

N-Acetylcysteine 150 mg/kg

Experimental group

Description:

Single intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes).

Treatment:

Drug: N-Acetyl cysteine