Actively Recruiting

Phase 3
Age: 40Years +
All Genders
NCT06225752

Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

Led by First Affiliated Hospital of Wannan Medical College · Updated on 2024-07-15

5452

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Wannan Medical College

Lead Sponsor

B

Beijing Tiantan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 40 years old or older
  • Diagnosed with ischemic stroke or transient ischemic attack (TIA)
  • Stroke or TIA occurred within 7 days before randomization
  • Main intracranial or extracranial arteries supplying the affected region are narrowed by more than 50%
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Cardiac sources of embolus such as atrial fibrillation, prosthetic valve, endocarditis, or patent foramen ovale
  • Stroke or TIA caused by arterial dissection, angioplasty, or vascular surgery
  • Use of probucol within 30 days before randomization
  • Known allergy, sensitivity, or intolerance to probucol
  • Myocardial disease within the past 30 days, including myocardial infarction or myocarditis
  • Have ventricular tachycardia, bradycardia, or tip-twist ventricular tachycardia
  • Prolonged Q-Tc interval or use of drugs that may cause Q-Tc prolongation
  • Cardiac syncope or unexplained fainting
  • Impaired liver function (ALT or AST more than twice normal) or kidney function (creatinine >1.5 times normal or eGFR less than 50 ml/min) at randomization
  • Anemia (hemoglobin <10 g/dL), low platelet count (<100 ×109/L), or low white blood cell count (<3 ×109/L) at randomization
  • Planned surgery or treatment requiring stopping the study drug during the study
  • Participation in another clinical trial with an investigational drug or device within the last 30 days
  • Pregnant or breastfeeding women; pregnant, trying to become pregnant, or of child-bearing potential and not using birth control
  • Severe non-cardiovascular illness with life expectancy less than 1 year
  • Serious drug or alcohol abuse in the past year
  • Mental, cognitive, or emotional disorders preventing understanding or following the study procedures or otherwise unsuitable as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affliated Hospital of Wannan Medical College

Wuhu, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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