💬In plain words
What the trial is, and whether it could suit you
Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease. In fact, aortic valve replacement remains the only treatment option.
CAS has been shown to be associated with Lp(a), LDL-C and PCSK9. Several observational studies indicated that the use of statins to decrease LDL-C levels was associated with the reduced incidence of CAS, but no randomized controlled trials (RCTs) showd that statins had any benefit on the progression of CAS. This may be related to the limited reduction of LDL-C by statin therapy. The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have emerged as a new lipid-lowering drug. On the basis of statin therapy, PCSK9 inhibitors can further reduce LDL-C and Lp(a) levels by 50% to 60% and 20% to 30%, respectively. Some studies reported that e
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Patients older than 18 years of age with mild or moderate calcific aortic stenosis (peak aortic jet velocity ≥ 2m/s and \< 4m/s or mean transvalvular gradients ≥ 20mmHg and \< 40mmHg), or asymptomatic severe aortic stenosis (peak aortic jet velocity ≥ 4m/s or mean transvalvular gradients ≥ 40mmHg and no symptoms and/or signs related to aortic stenosis and negative exercise treadmill test)
* Patients who are required to be treated with a stable statin (atorvastatin or rosuvastatin) dose for at least 4 weeks and to have an LDL-C level of 80 mg/dL or higher or between 60 and 80 mg/dL (to convert LDL-C values to mmol/L, multiply by 0.0259) with 1 major or 3 minor cardiovascular risk factors. Major risk factors include atherosclerotic cardiovascular disease, myocardial infarction or hospitalization for unstable angina in the preceding 2 years, or type 2 diabetes mellitus. Minor risk factors include current cigarette smoking, hypertension, low levels of high-density lipoprotein cholesterol, family history of premature coronary heart disease, high sensitivity C-reactive protein (hsCRP) level of 2 mg/L or higher (to convert hsCRP values to nmol/L, multiply by 9.524), or age 50 years or older for men and 55 years or older for women
* Patients agree to participate in the study by signing an informed consent form
Exclusion Criteria:
* Any previous treatment with PCSK9 inhibitors
* Patients who must be treated with long-term PCSK9 inhibitors
* Patients who cannot maintain statin and/or PCSK9 inhibitor use for 24 months
* Hypersensitivity to PCSK9 inhibitors and/or statin
* Fasting triglyceride (TG) levels \> 400mg/dL (4.5 mmol/L) at screening
* Thyroid hypofunction
* Active or chronic liver disease
* Severe renal dysfunction (eGFR \< 30 ml/min/1.73m2)
* History of cerebral hemorrhage
* History of alcohol or drug abuse
* Known active infection, or major hematological, metabolic, or endocrine dysfunction
* Patients who have been treated with systemic steroids or cyclosporine within the past 3 months
* Active malignant tumor
* Any life-threatening condition with life expectancy less than 12 months
* Severe mitral stenosis (valve area\<1cm2)
* Severe mitral or aortic regurgitation
* Patients who are scheduled to undergo heart valve surgery
* Left ventricular ejection fraction \< 30% or severe heart failure (NYHA class III or IV)
* The presence of a permanent pacemaker or defibrillator
* Arrhythmias that are not controlled by drugs
* Child-bearing potential without contraception
💊
What it tests
- PCSK9 inhibitors and statins with or without ezetimibe
- Statins with or without ezetimibe
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky