NCT06520904RecruitingPhase 4
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography in Patients With Premature Coronary Artery Disease: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 20 Jul 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- First Affiliated Hospital of Xinjiang Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT06520904
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 396
- From 1 Jul 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of PCSK9 inhibitors;
- Prior history of hemorrhagic stroke;
- Prior coronary artery bypass grafting or coronary intervention;
Other illness
- Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
Lab values
- Severe renal insufficiency (creatinine clearance \< 30 mL/min);
- Baseline triglycerides \> 5.6 mmol/L;
Other
- Inability to perform OCT imaging or unclear imaging;
- Severe hepatic dysfunction;
- Pregnant or lactating women;
- Life expectancy not exceeding 1 year;
- In the judgment of the investigator, unsuitable for this study for any reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.