Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ischemic Stroke, TIA

In brief

This study is a multicenter, double-blind, placebo-controlled, randomized clinical trial that aims to evaluate the efficacy of probucol on the reduction of the risk of recurrent stroke in patients with symptomatic intracranial or extracranial arterial stenosis.

Key facts

Study ID

NCT06225752

Run by

First Affiliated Hospital of Wannan Medical College

People needed

5452

Starts

2024-06-15

Expected to finish

2026-10-31

Last updated by the study team

2024-07-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 40 years or older than 40 years; 2.Ischemic stroke or transient ischemic attack (TIA); 3.Within 7 days from onset to randomization; 4.Main intracranial or extracranial arteries supplying the ischemic event region are narrowed by more than 50%; 5.Informed consent signed.

You may not qualify if…

• Presumed cardiac source of embolus, such as atrial fibrillation, prosthetic cardiac valve, endocarditis or patent foramen ovale;
• Stroke/TIA due to arterial dissection, angioplasty, or vascular surgery;
• Usage of probucol within 30 days before randomization;
• Known allergy or sensitivity or intolerance to probucol;
• Myocardial disease within the past 30 days, including myocardial infarction, myocarditis;
• With ventricular tachycardia, bradycardia, tip-twist ventricular tachycardia；
• With Q-Tc interval prolongation, or currently using drugs that may cause Q-Tc interval prolongation (male Q-Tc>450ms, female Q-Tc>470ms);
• Cardiac syncope or unexplained syncope;
• Impaired hepatic (ALT or AST > twice the upper limit of normal range) or kidney (creatinine exceeding 1.5 times of the upper limit of normal range or eGFR less than 50 ml/min) function at randomization;
• Anemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <100×109/L) or leucopenia (white blood cell <3×109/L) at randomization;
• Planned surgery or interventional treatment requiring cessation of the study drug during the study;
• Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days;
• Pregnant or lactating women; Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
• Severe non-cardiovascular comorbidity with a life expectancy of less than 1 years;
• Serious drug or alcohol abuse in the past 1 year；
• Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders, or to be an unsuitable candidate for the study for any other considered by the investigator.

Where it is running

• The First Affliated Hospital of Wannan Medical College — Wuhu, China (enrolling)

Full record on ClinicalTrials.gov

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