Using probucol to reduce recurrent strokes in patients with 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
This study is testing if a medication called probucol can help prevent strokes in people with narrowed arteries who are at risk for having another stroke.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 5452 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wannan Medical College Academic / other |
| Locations | 1 site (Wuhu) |
| Trial ID | NCT06225752 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who have experienced an ischemic stroke or TIA within the last 7 days and have significant arterial narrowing.
Not a fit: Patients with a presumed cardiac source of embolus or those with certain cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of recurrent strokes in patients with arterial stenosis.
How similar studies have performed: Other studies have explored the use of probucol for cardiovascular conditions, but this specific application for recurrent stroke prevention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wuhu
- The First Affliated Hospital of Wannan Medical College — Wuhu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.