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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049986
Enrollment
Unknown
Registered
2021-08-15
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

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Those patients with ischemic cerebrovascular disease will be preliminarily screened by carotid ultrasound to pick out the patient with carotid artery plaque and moderate stenosis (50%-69%). The high-resolution MRI will be furtherly carried out to evaluate the plaque volume and the degree of vascular lumen stenosis; 2.Those with age between 50 and 70 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; 5.Those patients that are not suitable for invasive treaments for carotid artery stenosis evaluated by clinicians including carotid endarterectomy and carotid stenting, or in the situation that the patient and family members refuse the corresponding invasive treatment.

Exclusion criteria

Exclusion criteria: 1. Patients who have suffered from hemorrhagic cerebrovascular disease, intracranial aneurysm, severe trauma or major surgery in the past; 2. Patients with severe sequelae from previous stroke (MRS score of 4 and above); 3. Severe stenosis of intracranial arteries (70%~99%); 4. Cardiac ischemic stroke patients; 5. Those with serious heart, liver, kidney and other serious concomitant diseases; 6. Hepatitis B or C, chronic alcoholism; 7. Combined with serious primary diseases such as hematopoietic system, mental patients; 8. Those who affect gastrointestinal absorption (after gastrointestinal ulcer or gastrointestinal surgery) and those with a history of gastrointestinal bleeding; 9. Those who have a history of allergy to the test drug; 10. Those who have had adverse reactions to aspirin and atorvastatin calcium in the past; 11. Those with contraindications to magnetic resonance examination; 12. Those deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Plaque composition and stability;

Secondary

MeasureTime frame
Plaque volume;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