Skip to content

Efficacy of Probucol in patients with Asymptomatic Intracranial Arterial Stenosis: a Multicenter, Prospective Cohort study (PROCESS study)

Efficacy of Probucol in patients with Asymptomatic Intracranial Arterial Stenosis: a Multicenter, Prospective Cohort study (PROCESS study)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091598
Enrollment
Unknown
Registered
2024-10-30
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Intracranial Arterial Stenosis

Interventions

Probucol group:None
Control group:None

Sponsors

West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. In accordance with the expert consensus on imaging evaluation of intracranial atherosclerotic stenosis, intracranial large artery stenosis =50% confirmed by CTA, MRA or DSA; 2. 18 = age =80 years old; 3. No previous ischemic stroke or TIA event.

Exclusion criteria

Exclusion criteria: 1. Suspected atrial fibrillation, known prosthetic heart valve, suspected endocarditis, patent foramen ovale and other congenital heart disease; A history of myocardial damage within 30 days before enrollment, including myocardial infarction, myocarditis; 2. Patients with arterial dissection; or have undergone angioplasty/vascular surgery; 3. Known allergy or intolerance to probucol; 4. Ventricular tachycardia, bradycardia, torsades de pointes; Have a prolonged Q-T interval or are taking other medications that may cause a prolonged Q-T interval; 5. History of cardiogenic syncope or unexplained syncope; 6. Hepatic insufficiency or renal insufficiency; (Hepatic insufficiency was defined as an ALT value >2 times the upper limit of normal or an AST value >2 times the upper limit of normal; Renal insufficiency was defined as serum creatinine >1.5 times the upper limit of normal or glomerular filtration rate <50mL/min). 7. It is expected that surgical treatment or intracranial artery stent implantation will be required during the study period, which may require discontinuation of the trial drug; 8. Have participated in or are undergoing a drug or device clinical trial within the past 30 days; 9. Pregnant or lactating women; 10. Inability to understand or comply with the study due to mental disorders, cognitive or emotional disorders or other reasons considered by the researcher to be inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
New ischemic stroke events within 1 year;

Secondary

MeasureTime frame
Changes in the rate of vascular stenosis after 1 year follow-up;All-cause mortality;The change of serum LDL level after 1 year;

Countries

China

Contacts

Public ContactHe Li

West China Hospital, Sichuan University

heli2003new@126.com+86 189 8060 1670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026