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New treatment option for Aortic Stenosis
Official title Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis
ClinicalTrials.gov ID: NCT04968509
What this study is testing
What is PCSK9 inhibitors and statins with or without ezetimibe?
PCSK9 inhibitors and statins with or without ezetimibe is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for aortic stenosis.
Also referred to as Proprotein convertase subtilisin/kexin type 9 inhibitors, Hydroxymethylglutaryl-Coenzyme A Reductase inhibitors.
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
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- 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...
- 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...
- Patients agree to participate in the study by signing an informed consent form
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- Patients agree to participate in the study by signing an informed consent form
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 Beijing, Beijing Municipality, China. 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.