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.
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. During the study period, 5452 patients at intermediate risk for ischemic stroke or TIA will be enrolled from 100 centers.To evaluate whether probucol, as compared with placebo, reduces the risk of recurrent stroke in patients at high risk for ischemic stroke or TIA within 7 days of onset.Patients in one arm will receive probucol initiated with a dose of 1000 mg per day on days 1 through 30, and continuing with 500 mg per day after day 31, and those in the other arm will receive an equivalent placebo drug. Study visits will be performed on the day of randomization, at discharge, at day 90 and at 1 year and then followed up annually until the occurrence of the endpoint event or the end of the study. In addition, patients will be followed up at any time when new clinical symptoms of the neurologic system and suspicious events occur, including worsening of the original ischemic event and the appearance of new transient or persistent neurologic symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,452
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.)
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.)
The First Affliated Hospital of Wannan Medical College
Wuhu, China
RECRUITINGRecurrent stroke event
Ischemic or hemorrhagic stroke
Time frame: within 1 year
Recurrent ischemic stroke event
Incidence of any new ischemic stroke
Time frame: within 1 year
Composite vascular events
Including ischemic stroke, hemorrhagic stroke, myocardial infarction and vascular death
Time frame: within 1 year
Poor functional outcome
Defined as a modified Rankin Scale (mRS) score ≥3(The mRS Scale is used to evaluate the recovery of neurological function in stroke patients. It consists of a seven-point scale, with Grade 0 indicating no symptoms at all. Grade 1 represents the presence of symptoms but without significant disability, allowing for the performance of regular jobs and activities. Grade 2 signifies mild disability where individuals are unable to perform all work and activities but can manage personal affairs independently. Grade 3 indicates moderate disability requiring assistance from others for walking without aid. Grade 4 denotes severe disability where individuals cannot walk unassisted and are unable to care for their own needs. Grade 5 represents severe disability with bedridden status, incontinence, and necessitating continuous care round-the-clock. Finally, Grade 6 signifies death.)
Time frame: within 1 year
All-cause mortality
Death from any cause
Time frame: within 1 year
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