Evaluating alirocumab for treating neoatherosclerosis in coronary artery disease
Prospective Observational Study for Lesion of Neoatherosclerosis: The Efficacy of Alirocumab for the Neoatherosclerosis Reaction Investigated by Serial Optical Coherence Tomography
This study is testing if a new drug called alirocumab can help people with coronary artery disease and neoatherosclerosis feel better compared to standard statin treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 31 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Kobe University Industry-sponsored |
| Drugs / interventions | aliclumab, alirocumab |
| Locations | 1 site (Kobe, Hyogo) |
| Trial ID | NCT03533959 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy of alirocumab in treating in-stent neoatherosclerosis compared to standard statin therapy using optical coherence tomography (OCT). Patients who have undergone drug-eluting stent implantation and have detectable neoatherosclerosis will be enrolled and categorized into two groups: one receiving alirocumab alongside rosuvastatin and the other receiving rosuvastatin alone. The outcomes of both groups will be compared to assess the effectiveness of alirocumab in this context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and over who have undergone drug-eluting stent implantation and have detectable neoatherosclerosis.
Not a fit: Patients who have previously received treatment with PCSK9 inhibitors or those whose treatment was interrupted before follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with neoatherosclerosis, potentially improving their cardiovascular health.
How similar studies have performed: While there is ongoing research in this area, the specific use of alirocumab for neoatherosclerosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The age at the time of consent acquisition is 20 years old or over. 2. OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent 3. lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed. 4. Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed. 5. Document consent has been obtained from the subject person to this research. Exclusion Criteria: 1. Patients who have received treatment with PCSK 9 inhibitor in the past 2. Patients whose treatment was interrupted before follow-up catheterization during the observation period 3. Patients underwent LDL apheresis. 4. In the case that the researchers judges it as inappropriate as the object of this research.
Where this trial is running
Kobe, Hyogo
- Kobe University Graduate School of Medicine, Department of Cardiology — Kobe, Hyogo, Japan (Recruiting)
Study contacts
- Study coordinator: Hiromasa Otake, M.D., Ph.D
- Email: hotake@med.kobe-u.ac.jp
- Phone: +81-78-382-5111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.