NCT05462262Active, not recruiting
Intensive Lipid-lowering for Plaque and Major Adverse Cardiovascular Events in Low to Intermediate 10-year ASCVD Risk Population
Effects of Intensive Lipid-lowering on Coronary Atherosclerotic Plaque Phenotype and Major Adverse Cardiovascular Events in Adults With Low to Intermediate 10-year ASCVD Risk: a Prospective, Randomized, Open-label, Blinded Endpoint Analysis(PROBE)
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
Current guidelines recommend moderate-intensity lipid-lowering therapy (goal for LDL-C \<2.6 mmol/L or 30%-50% reduction from baseline) for patients with intermediate 10-year ASCVD risk. In these patients, early coronary atherosclerotic plaques detected by coronary CT angiography are common, but further interventions are lacking. This study aims to analyze whether intensive lipid-lowering therapy (goal for LDL-C \<1.8 mmol/L or ≥50% reduction from baseline) could delay the progression of coronary atherosclerotic lesions and reduce the adverse cardiovascular events in these target patients.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 2900 (estimated)
- First submitted
- 7 Jul 2022
- Start date
- 10 Oct 2022
- Primary completion date
- Jul 2029
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05462262
What you commit to
- Study type: Interventional
- Planned participants: 2900
- From 10 Oct 2022 to the primary completion date, Jul 2029
- 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any planned surgical procedure for the treatment of atherosclerosis
- Concurrent long-term immunosuppressive therapy
- Participation in another clinical trial concurrently or within 30 days before screening
Other illness
- Myocardial infarction, coronary revascularization, or severe/unstable angina before or within 1 month of screening
- Active liver disease or hepatic dysfunction (defined as alanine aminotransferase or aspartate aminotransferase\> 3 times the upper limit of normal)
- Nephrotic syndrome
- Diabetes mellitus
- Uncontrollable hypertension
- Hypersensitivity to statins
- Gastrointestinal diseases affecting drug absorption or history of gastrointestinal surgery
- Survival-limiting diseases
Lab values
- Combination with serious cardiovascular diseases, including
- Heart failure (ejection fraction \<30%)
- Arrhythmias (persistent atrial flutter/atrial fibrillation, second-degree or third-degree atrioventricular block)
- Hemodynamically important valvular disease
- Hemodynamically important congenital heart disease
- Stroke
Other
- Unexplained creatine phosphokinase\> 6 times the upper limit of normal
- Uncontrollable hypothyroidism
- Pregnant or breastfeeding
- Other unsuitable situations deemed by physicians
Who the study is looking for
- Age 40-75 years
- Low to Intermediate 10-year atherosclerotic cardiovascular disease (ASCVD) risk using pooled cohort equations (PCE).
- Coronary CT angiography shows atherosclerotic plaque in the main coronary vessels (\>2mm diameter) with luminal stenosis \<70%
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.