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NCT06225752RecruitingPhase 3

Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

A Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial of Probucol in Reducing the Risk of Recurrent Stroke in Patients With Symptomatic Intracranial and Extracranial Large-artery Stenosis

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
5452 (estimated)
First submitted
17 Jan 2024
Start date
15 Jun 2024
Primary completion date
30 Apr 2028
Lead sponsor
First Affiliated Hospital of Wannan Medical College
Diseases
Stroke
NCT number
NCT06225752

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 5452
  • From 15 Jun 2024 to the primary completion date, 30 Apr 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Usage of probucol within 30 days before randomization;
  • With Q-Tc interval prolongation, or currently using drugs that may cause Q-Tc interval prolongation (male Q-Tc\>450ms, female Q-Tc\>470ms);
  • 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;
  • Serious drug or alcohol abuse in the past 1 year;

Other illness

  • 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;
  • Known allergy or sensitivity or intolerance to probucol;
  • Myocardial disease within the past 30 days, including myocardial infarction, myocarditis;
  • Cardiac syncope or unexplained syncope;
  • 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.

Lab values

  • 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;

Other

  • With ventricular tachycardia, bradycardia, tip-twist ventricular tachycardia;
  • 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;

Who the study is looking for

  • 1.40 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.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affliated Hospital of Wannan Medical College
Coordinator of this site? Confirm its status
WuhuChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.