Using probucol to reduce recurrent strokes in patients with artery stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, placebo-controlled, randomized clinical trial evaluates the efficacy of probucol in reducing the risk of recurrent strokes in patients with symptomatic intracranial or extracranial arterial stenosis. A total of 5452 patients at intermediate risk for ischemic stroke or TIA will be enrolled from 100 centers. Participants will receive either probucol or a placebo, with follow-up visits scheduled at various intervals to monitor outcomes and any new neurological symptoms. The study aims to determine if probucol can significantly lower the incidence of recurrent strokes within a year.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

1. Presumed cardiac source of embolus, such as atrial fibrillation, prosthetic cardiac valve, endocarditis or patent foramen ovale;
2. Stroke/TIA due to arterial dissection, angioplasty, or vascular surgery;
3. Usage of probucol within 30 days before randomization;
4. Known allergy or sensitivity or intolerance to probucol;
5. Myocardial disease within the past 30 days, including myocardial infarction, myocarditis;
6. With ventricular tachycardia, bradycardia, tip-twist ventricular tachycardia；
7. With Q-Tc interval prolongation, or currently using drugs that may cause Q-Tc interval prolongation (male Q-Tc\>450ms, female Q-Tc\>470ms);
8. Cardiac syncope or unexplained syncope;
9. 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;
10. Anemia (haemoglobin \<10g/dL), thrombocytopenia (platelet count \<100×109/L) or leucopenia (white blood cell \<3×109/L) at randomization;
11. Planned surgery or interventional treatment requiring cessation of the study drug during the study;
12. Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days;
13. Pregnant or lactating women; Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
14. Severe non-cardiovascular comorbidity with a life expectancy of less than 1 years;
15. Serious drug or alcohol abuse in the past 1 year；
16. 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's running

• The First Affliated Hospital of Wannan Medical College
  Wuhu, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.