Clinical Trials Logo

Clinical Trial Summary

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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05030428
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date November 30, 2021
Completion date March 15, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT01572259 - Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism Phase 3
Completed NCT03096288 - Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity Phase 4
Enrolling by invitation NCT03911284 - The Learning Registry
Recruiting NCT03705234 - A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease Phase 3
Completed NCT01663402 - ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab Phase 3
Completed NCT03597412 - Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM Phase 4
Completed NCT00185185 - Olmesartan Medoxomil in Atherosclerosis Phase 3
Completed NCT02991118 - Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk Phase 3
Completed NCT02988115 - Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant Phase 3
Recruiting NCT04215237 - How Atorvastatin Affects the Gut Flora and Metabolomics? N/A
Recruiting NCT04462159 - The Young Heart Study N/A
Not yet recruiting NCT03505073 - Association Between Dietary Habits and Risk Factors for Atherosclerotic Cardiovascular Diseases in Assiut Governorate
Recruiting NCT01330602 - Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis N/A
Recruiting NCT04924686 - Changes of Muramyl Dipeptide in Intestinal and Extra-intestinal Diseases
Enrolling by invitation NCT04789278 - Incidental Coronary Calcification Quality Improvement Project N/A
Recruiting NCT03403556 - High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes Phase 4
Active, not recruiting NCT03060577 - An Extension Trial of Inclisiran Compared to Evolocumab in Participants With Cardiovascular Disease and High Cholesterol Phase 2
Terminated NCT00856817 - Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation Phase 4
Active, not recruiting NCT04271280 - Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
Recruiting NCT04929249 - A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE) Phase 3