Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

Launched by FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called probucol to see if it can help reduce the risk of having another stroke in people who have already experienced symptoms related to narrowed arteries in the brain or neck. The trial is open to adults aged 40 and older who have had either an ischemic stroke (a type of stroke caused by a blockage) or a transient ischemic attack (TIA), which is a temporary blockage that can lead to a stroke. To participate, individuals must sign a consent form and be enrolled within seven days of their symptoms.

Participants in the study will be randomly assigned to receive either probucol or a placebo (a harmless pill with no active medication) without knowing which one they are receiving. Throughout the trial, they will be monitored closely to assess how well the treatment works. It’s important to note that certain health conditions, such as specific heart problems or recent surgeries, may prevent someone from joining the study. Overall, this trial aims to provide valuable information on how effective probucol may be in preventing future strokes for people with narrowed arteries.

Gender

ALL

Eligibility 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.