Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

NCT06225752 | Recruiting Phase 3 DMC

• 1 other identifier: 2023AH040246
• Study Type: interventional
• Target: 5,452
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; TIA

Keywords

Probucol; Recurrent stroke

Outcome Measures

Primary Outcomes (1)

• Recurrent stroke event

  Ischemic or hemorrhagic stroke

  within 1 year

Secondary Outcomes (4)

• Recurrent ischemic stroke event

  within 1 year

• Composite vascular events

  within 1 year

• Poor functional outcome

  within 1 year

• All-cause mortality

  within 1 year

Other Outcomes (4)

• Change in levels of oxidized low-density lipoprotein cholesterol (Ox-LDL)

  within 1 year

• Change in the rate of responsible vessel stenosis

  within 1 year

• Adverse events

  within 1 year

Study Arms (2)

Probucol Group

EXPERIMENTAL

The study drug should be started as soon as possible within 7 days after symptom onset.

Drug: Probucol

Placebo Probucol Group

PLACEBO COMPARATOR

The study drug should be started as soon as possible within 7 days after symptom onset.

Drug: Placebo probucol

Interventions

Probucol DRUG

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.)

Probucol Group

Placebo probucol DRUG

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.)

Placebo Probucol Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Myocardial disease within the past 30 days, including myocardial infarction, myocarditis;
• With ventricular tachycardia, bradycardia, tip-twist ventricular tachycardia；
• With Q-Tc interval prolongation, or currently using drugs that may cause Q-Tc interval prolongation (male Q-Tc\>450ms, female Q-Tc\>470ms);
• Cardiac syncope or unexplained syncope;
• 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;
• Anemia (haemoglobin \<10g/dL), thrombocytopenia (platelet count \<100×109/L) or leucopenia (white blood cell \<3×109/L) at randomization;
• Planned surgery or interventional treatment requiring cessation of the study drug during the study;
• Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days;
• Pregnant or lactating women; Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
• Severe non-cardiovascular comorbidity with a life expectancy of less than 1 years;
• Serious drug or alcohol abuse in the past 1 year；

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

The First Affliated Hospital of Wannan Medical College

Wuhu, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Probucol

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: June 15, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)