NCT06520904 Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
| NCT ID | NCT06520904 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First Affiliated Hospital of Xinjiang Medical University |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 396 participants in total. It began in 2024-07-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.
Eligibility Criteria
Inclusion Criteria: * Men aged 18-55 years and women aged 18-65 years; * CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level); * LDL-C \>3.4 mmol/L without regular statin therapy or LDL-C \>1.8 mmol/L after 4 weeks of statin lipid-lowering therapy. Exclusion Criteria: * Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy; * Prior use of PCSK9 inhibitors; * Prior history of hemorrhagic stroke; * Prior coronary artery bypass grafting or coronary intervention; * Inability to perform OCT imaging or unclear imaging; * Severe renal insufficiency (creatinine clearance \< 30 mL/min); * Severe hepatic dysfunction; * Baseline triglycerides \> 5.6 mmol/L; * Pregnant or lactating women; * Life expectancy not exceeding 1 year; * In the judgment of the investigator, unsuitable for this study for any reason.
Contact & Investigator
Zhenyan Fu, PhD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Xinjiang Medical University
Frequently Asked Questions
Who can join the NCT06520904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06520904 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06520904 currently recruiting?
Yes, NCT06520904 is actively recruiting participants. Contact the research team at 463387160@qq.com for enrollment information.
Where is the NCT06520904 trial being conducted?
This trial is being conducted at Ürümqi, China.
Who is sponsoring the NCT06520904 clinical trial?
NCT06520904 is sponsored by First Affiliated Hospital of Xinjiang Medical University. The principal investigator is Zhenyan Fu, PhD at First Affiliated Hospital of Xinjiang Medical University. The trial plans to enroll 396 participants.