Last updated: May 7, 2024
Sponsor: Beijing Anzhen Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Heart Valve Disease
Congestive Heart Failure
Heart Defect
Treatment
PCSK9 inhibitors and statins with or without ezetimibe
Statins with or without ezetimibe
Clinical Study ID
NCT04968509
EPISODE
2022-2-1052
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ≥ 20mmHgand < 40mmHg), or asymptomatic severe aortic stenosis (peak aortic jet velocity ≥ 4m/sor mean transvalvular gradients ≥ 40mmHg and no symptoms and/or signs related toaortic stenosis and negative exercise treadmill test)
- Patients who are required to be treated with a stable statin (atorvastatin orrosuvastatin) dose for at least 4 weeks and to have an LDL-C level of 80 mg/dL orhigher 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 factorsinclude atherosclerotic cardiovascular disease, myocardial infarction orhospitalization for unstable angina in the preceding 2 years, or type 2 diabetesmellitus. Minor risk factors include current cigarette smoking, hypertension, lowlevels of high-density lipoprotein cholesterol, family history of premature coronaryheart 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 formen and 55 years or older for women
- Patients agree to participate in the study by signing an informed consent form
Exclusion
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 orIV)
- The presence of a permanent pacemaker or defibrillator
- Arrhythmias that are not controlled by drugs
- Child-bearing potential without contraception
Study Design
Total Participants: 160
Treatment Group(s): 2
Primary Treatment: PCSK9 inhibitors and statins with or without ezetimibe
Phase: 3
Study Start date:
March 22, 2024
Estimated Completion Date:
January 31, 2028
Connect with a study center
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing 100000
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.