Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Purpose
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
Condition
- Atherosclerotic Cardiovascular Disease
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Fasting LDL-C ≥ 70 mg/dL at randomization visit 2. Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD 3. Established CV disease defined as ANY of the following three conditions 1. Spontaneous Myocardial infarction ≥ 4 weeks from screening visit 2. History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit 3. Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.
Exclusion Criteria
- Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit 2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit 3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit 4. Heart failure NYHA class III or IV 5. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver 6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years 7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years 8. History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit 9. Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- randomized, double-blind, parallel group, placebo-controlled, multi-center, event-driven study
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Double-blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Inclisiran sodium |
Subcutaneous injection |
|
|
Placebo Comparator Placebo |
Subcutaneous injection |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Novartis Pharmaceuticals
Study Contact
Detailed Description
Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.