A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT06431763
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria:<br><br> 1. Fasting LDL-C = 70 mg/dL at screening<br><br> 2. Participants must be on a stable (= 4 weeks) and well-tolerated lipid-lowering<br> regimen (with or without Ezetimibe [10mg]) that must include a high-intensity statin<br> therapy with either atorvastatin =40 mg QD or rosuvastatin =20 mg QD in a maximally<br> tolerated or maximally approved dose at screening<br><br> 3. Participants categorized as very high or high CV risk, as defined below:<br><br> - Very high risk participants with at least one of the following:<br><br> - Documented ASCVD: ACS: Unstable angina or myocardial infarction, Stable<br> angina, Coronary revascularization, Unequivocally documented ASCVD upon<br> prior imaging, Stroke and Transient Ischaemic Attack (TIA), Peripheral<br> artery disease (PAD)<br><br> - Diabetes mellitus (DM) with target organ damage (defined as<br> microalbuminuria, retinopathy, or neuropathy), or at least = 3 major risk<br> factors, or early onset of Type 1 DM of long duration (< 20 years)<br><br> - A calculated SCORE2 = 7.5 % for age < 50 years; SCORE2 = 10 % for age<br> 50-69 years; SCORE2-OP = 15 % for age = 70 years to estimate 10-year risk<br> of fatal and non-fatal CVD<br><br> - Pre-existing diagnosis of heterozygous familial hyper-cholesterolemia<br> (HeFH) with ASCVD or with another major risk factor OR<br><br> - High risk participants with at least one of the following:<br><br> - Markedly elevated single risk factors, in particular total cholesterol ><br> 310 mg/dL, LDL-C > 190 mg/dL, or blood pressure = 180/110 mmHg<br><br> - Pre-existing diagnosis of HeFH without other major risk factors<br><br> - DM without target organ damage (defined as microalbuminuria, retinopathy,<br> or neuropathy), with DM duration = 10 years or other additional risk<br> factor<br><br> - Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2)<br><br> - A calculated SCORE2 2.5 to < 7.5 % for age < 50 years; SCORE2 5 to < 10 %<br> for age 50-69 years; SCORE2-OP 7.5 to < 15 % for age = 70 years to<br> estimate 10-year risk of fatal and non-fatal CVD as defined by the<br> cardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al<br> 2020), and updated SCORE2 and SCORE2-OP (Hageman et al 2021, de Vries et<br> al 2021, Visseren et al 2021). Further details for documented ASCVD will<br> be provided in the protocol.<br><br> 4. Fasting triglyceride < 400 mg/dL at screening<br><br>Exclusion Criteria:<br><br> 1. Acute coronary syndrome, ischemic stroke, peripheral arterial revascularization<br> procedure or amputation due to atherosclerotic disease < 4 months prior to screening<br> visit or V1.<br><br> 2. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or<br> coronary re-vascularization within 6 months after screening visit.<br><br> 3. Heart failure NYHA class IV at screening or V1.<br><br> 4. Participants on more than one other lipid-lowering drug on top of statin at<br> screening visit.<br><br> 5. Previous treatment with a mAb directed towards PCSK9 (e.g., evolocumab, alirocumab)<br> or planned use after screening visit.<br><br> 6. Previous treatment prior to screening with BPA within 90 days<br><br> 7. Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy, either<br> as an investigational or marketed drug.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change from baseline in LDL-C levels
- Secondary Outcome Measures
Name Time Method Percent change from baseline in LDL-C levels in patients without Ezetimibe;Percent change from baseline in LDL-C levels in patients with Ezetimibe;Number of participants by individual responsiveness;Absolute change from Baseline in LDL-C;Percent change from Baseline in LDL-C levels;Percent change from Baseline in LDL-C levels;Mean change from baseline in MMAS-8 over time;Mean change from Baseline in TSQM over time;Mean change from Baseline in SF-BPI over time;Proportion of participants with clinically significant change from Baseline in SF-BPI