Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorFirst Affiliated Hospital of Wannan Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Presumed cardiac source of embolus, such as atrial fibrillation, prosthetic cardiac valve, endocarditis or patent foramen ovale;
Stroke/TIA due to arterial dissection, angioplasty, or vascular surgery;
Usage of probucol within 30 days before randomization;
Known allergy or sensitivity or intolerance to probucol;
Trial design
Design model
Parallel
Treatments tested in this trial
Probucol
DrugInclusion 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.)
Placebo probucol
DrugInclusion 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.)
Treatment groups
5,452 Participants
are divided into 2 treatment groupsGroup A: Probucol GroupExperimental treatment 1 intervention
Group B: Placebo Probucol GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrent stroke event
Ischemic or hemorrhagic stroke
Time frame
within 1 yearSecondary outcomes
1
Recurrent ischemic stroke event
Incidence of any new ischemic stroke
Time frame
within 1 year2
Composite vascular events
Including ischemic stroke, hemorrhagic stroke, myocardial infarction and vascular death
Time frame
within 1 year3
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 year4
All-cause mortality
Death from any cause
Time frame
within 1 yearOther outcomes
1
Change in levels of oxidized low-density lipoprotein cholesterol (Ox-LDL)
Ox-LDL is a component specific to the atherosclerotic lesion area that is not present in normal arterial vascular tissue and is elevated in atherosclerotic strokes
Time frame
within 1 year2
Change in the rate of responsible vessel stenosis
Stenosis of the responsible vessel at enrollment \>50%
Time frame
within 1 year3
Adverse events
The difference in the proportion of adverse events (AEs) between Probucol and the placebo group
Time frame
within 1 year4
Severe adverse events
The difference in the proportion of serious adverse events (SAEs) between Probucol and the placebo group;
Time frame
within 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Wannan Medical College
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Source ClinicalTrials.gov