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A study of idebenone in patients with asymptomatic carotid plaque and stenosis: a randomized, double-blind, placebo-controlled single-center clinical trial

A study of idebenone in patients with asymptomatic carotid plaque and stenosis: a randomized, double-blind, placebo-controlled single-center clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042892
Enrollment
Unknown
Registered
2021-01-31
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

carotid plaque and stenosis

Interventions

control group:placebo

Sponsors

Qilu Hospital, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Those asymptomatic patients with normal blood lipid levels will be preliminarily screened by carotid ultrasound to pick out the patient with carotid artery plaque and mild stenosis (25%-49%). The high-resolution MRI will be carried out to evaluate the plaque volume, the degree of vascular lumen stenosis and the properties of the plaque including the size of the lipid core area, hemorrhage in the plaque, the fibrous cap of the plaque, calcification, thrombosis and inflammation; 2.Those with age between 50 and 65 years; 3.Those who can persist in taking the experimental drugs for a long time; 4.Those who agree to take part in the clinical research and sign the informed consent document.

Exclusion criteria

Exclusion criteria: 1.Those who have suffered from acute ischemic or hemorrhagic cerebrovascular diseases, acute coronary syndrome, severe trauma or major surgery in the past; 2.Those with serious heart, liver, kidney or other serious complications; 3.Those with chronic hepatitis B, chronic hepatitis C or chronic alcoholism; 4.Those with hypothyroidism, gout, acute or chronic liver and gallbladder disease; 5.Those with severe infection; 6.Those with uncontrolled diabetes or poorly controlled diabetes (fasting blood glucose >= 8.0mmol/L after standardized application of hypoglycemic drugs); 7.Those with severe primary diseases in liver, kidney and hematopoietic system or those with mental illness; 8.Those with poor gastrointestinal absorption after gastrointestinal ulcer or gastrointestinal surgery; 9.Those who are breastfeeding, pregnant or preparing to become pregnant; 10.Those with a history of allergies to test drugs; 11.Those evaluated by ultrasound showing that the plaque seriously affects carotid blood flow; 12.Those who have the history of long-term use of statin, anticoagulant drugs or antiplatelet drugs (>3 months); 13.Those 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 ContactPengfei Lin

Qilu Hospital, Shandong University

lpfsdu@foxmail.com+86 18560085518

Outcome results

None listed

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