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Idebenone in patients with carotid plaque and moderate stenosis: a randomized, double-blind, placebo-controlled, single-center clinical trial

Idebenone in patients with carotid plaque and moderate stenosis: a randomized, double-blind, placebo-controlled, single-center clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049611
Enrollment
Unknown
Registered
2021-08-06
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

carotid plaque with stenosis

Interventions

control group:Placebo

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with ischemic cerebrovascular disease with carotid plaque and moderate stenosis (50%-69%) were initially screened by carotid ultrasound or cervical vascular MRA, and further accurate assessment of carotid artery lumen stenosis by high-resolution MRI was moderate stenosis (50%-69%); 2. Aged 50-70 years; 3. Those who can insist on taking this experimental drug for a long time; 4. Those who agree to participate in this clinical study and sign the informed consent; 5. Invasive treatments for carotid artery stenosis that are not suitable for carotid artery stenosis after evaluation by clinicians include carotid endarterectomy and carotid stenting, or the patients and their families refuse to undergo corresponding invasive treatments.

Exclusion criteria

Exclusion criteria: 1. Patients who have suffered from hemorrhagic cerebrovascular disease ,intracranial aneurysm, severe trauma or after major surgery; 2. Patients with severe sequelae from previous strokes (MRS score 4 points and above); 3. Patients with severe intracranial artery stenosis (70%~99%); 4. Patients with cardiogenic ischemic stroke; 5. Patients with serious heart, liver, kidney diseases or other serious concomitant diseases; 6. Patients with chronic hepatitis B, chronic hepatitis C or chronic alcoholism; 7. Patients with severe primary diseases such as hematopoietic system disease or mental illness; 8. Those with poor gastrointestinal absorption after gastrointestinal ulcer or gastrointestinal surgery; 9. Patients with a history of allergies to test drugs; 10.Patients who have had previous adverse reactions to aspirin and rosuvastatin; 11.Patients who are contraindicated in MRI; 12.Patients who are not believed to be suitable for enrollment by researchers.

Design outcomes

Primary

MeasureTime frame
Carotid plaque volume;

Secondary

MeasureTime frame
Degree of vascular stenosis;

Countries

China

Contacts

Public ContactLin Pengfei

Qilu Hospital of Shandong University

lpfsdu@foxmail.com+86 18560085518

Outcome results

None listed

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