N-ACETYLCYSTEINE FOR THROMBOLYSIS IN ACUTE STROKE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2024-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous N-Acetylcysteine for the Treatment of Acute Ischemic Stroke

NCT04918719

Acute Ischemic Stroke

UNKNOWN PHASE2

Pre-stroke Cognitive Status and Thrombolytic Therapy

NCT01713491

Brain Ischemia Adverse Effect of Thrombolytic Drugs Impaired Cognition +1 more

COMPLETED

Ketamine for Thrombolysis in Acute Ischemic Stroke

NCT02258204

Stroke

UNKNOWN PHASE1/PHASE2

Neutrophil Extracellular Traps and Thrombolysis in the Acute Stroke

NCT02476188

Acute Stroke

COMPLETED NA

Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients

NCT02907736

Acute Stroke

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Ischemic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N-Acetylcysteine 150 mg/kg

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

Group Type EXPERIMENTAL

N-Acetyl cysteine

Intervention Type DRUG

Administered as specified in the treatment arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-Acetyl cysteine

Administered as specified in the treatment arm

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HIDONAC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No