Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Recruiting
Phase 3Interventional Study
Ischemic StrokeTIA
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
5,452 (estimated)
Sponsor
First Affiliated Hospital of Wannan Medical College · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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.
Exclu…
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.
Contacts
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