Using OFR Software to Observe the Effects of Inclisiran Combined With Statins on the Morphology and Vascular Function of Coronary Vulnerable Plaques
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 70%, and the lesion was confirmed by OCT and OFR analysis, in which the target lesion contained at least one vulnerable plaque (the thinnest fibrous cap thickness was ≤65um, and the lipid core was ≥ 90), and the target vessel did not need further percutaneous coronary intervention (PCI); 3. Patients have been treated with statins for ≥4 weeks, but their LDL-C level were still ≥ 70 mg/dl (≥ 1.8 mmol/l).
Locations
Other Locations
China
NanJing Frist Hospital
RECRUITING
Nanjing
Contact Information
Primary
Peina Meng, MD
527114121@qq.com
8615805199492
Backup
Fei Ye, MD
doctor_ye@126.com
8618951670287
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Inclisiran＋rosuvastatin group
Inclisiran sodium＋rosuvastatin 20mg group: Rosuvastatin was given 20mg daily for one year, and Inclisiran was given three times in total. After the first injection, 284mg(1.5ml solution) was injected subcutaneously, the second injection was 3 months after the first injection, and the third injection was in the ninth month.
Placebo_comparator: Rosuvastatin group
Rosuvastatin group: Rosuvastatin 20mg daily for one year.
Related Therapeutic Areas
Sponsors
Leads: Nanjing First Hospital, Nanjing Medical University