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New treatment option for Coronary Artery Disease
Official title Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography
ClinicalTrials.gov ID: NCT06863545
What this study is testing
What is PCSK9 inhibitors and background lipid-modifying therapy?
PCSK9 inhibitors and background lipid-modifying therapy is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with standard LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be ≥ 18 years.
- Patients with at least one target lesion meet CCTA-detected plaque features of the following:
- Degree of stenosis ≥ 50% or plaque burden ≥ 70%
- At least 2 of the following high-risk plaque features: i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium
- The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.
You likely can't join if
- Target lesions underwent or planned to revascularization.
- Patients with acute coronary syndrome.
- New York Heart Association class III or IV, or last known left ventricular ejection fraction \< 30%.
- Uncontrolled or recurrent ventricular tachycardia.
- Homozygous familial hypercholesterolemia.
- Active liver disease or hepatic dysfunction.
See the full eligibility criteria
- Subject must be ≥ 18 years.
- Patients with at least one target lesion meet CCTA-detected plaque features of the following:
- Degree of stenosis ≥ 50% or plaque burden ≥ 70%
- At least 2 of the following high-risk plaque features: i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium
- The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.
- Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed...
- Target lesions underwent or planned to revascularization.
- Patients with acute coronary syndrome.
- New York Heart Association class III or IV, or last known left ventricular ejection fraction \< 30%.
- Uncontrolled or recurrent ventricular tachycardia.
- Homozygous familial hypercholesterolemia.
- Active liver disease or hepatic dysfunction.
- Failed CCTA plaque analysis.
- Non-cardiac co-morbid conditions with life expectancy \< 2 years.
- Pregnant and/or lactating women.
- Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Hangzhou, China
- Jinhua, China
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China; Hangzhou, China; Jinhua, China; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.