Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06225752

PHASE3

Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

Sponsor: First Affiliated Hospital of Wannan Medical College

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5452

Start Date

2024-06-15

Completion Date

2026-10-31

Last Updated

2024-07-15

Healthy Volunteers

Conditions

Ischemic Stroke TIA

Interventions

DRUG

Probucol

Inclusion Days 1-30: Probucol 1000mg/day (500mg per dose, twice daily, a minimum of 4 hours should elapse between each pair of doses.) Inclusion Days 31 and beyond: Probucol 500mg/day (250mg per dose, twice daily, a minimum of 4 hours should elapse between each pair of doses.)

DRUG

Placebo probucol

Inclusion Days 1-30: Placebo Probucol 1000mg/day (500mg per dose, twice daily, a minimum of 4 hours should elapse between each pair of doses.) Inclusion Days 31 and beyond: Placebo Probucol 500mg/day (250mg per dose, twice daily, a minimum of 4 hours should elapse between each pair of doses.)

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.

Locations (1)

The First Affliated Hospital of Wannan Medical College

Wuhu, China