| Leqvio (inclisiran) / Novartis |
2021-003759-40: Study to understand if inclisiran is better than a placebo at lowering LDL-cholesterol, is safe and can have an impact on patient quality of life, when given along with other lipid lowering medications. Estudio para comprender si el inclisiran es mejor que un placebo para reducir el colesterol LDL, es seguro y puede tener un impacto en la calidad de vida del paciente, cuando se administra junto con otros medicamentos para reducir los lípidos. |
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| Ongoing | 4 | 1760 | Europe | Inclisiran, KJX839, Solution for injection in pre-filled syringe | Novartis Pharma AG, Novartis Pharma AG | Hypercholesterolemia Hipercolesterolemia, Hypercholesterolemia, specifically elevated low density lipoprotein cholesterol (LDL-C), is one of the major risk factors for the development of coronary heart disease (CHD) La hipercolesterolemia,específicamente elevados niveles de colesterol de lipoproteínas de baja densidad (LDL-C),es uno de los principales factores de riesgo para el desarrollo de enfermedad coronaria, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2023-000166-33: Semmelweis Lipid Center for high-risk patients Semmelweis Lipid Centrum magas rizikójú betegeknek |
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| Not yet recruiting | 4 | 200 | Europe | Injection, Leqvio | Semmelweis University, Novartis Hungary Ltd., Ministry of Innovation and Technology | primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in atherosclerotic cardiovascular disease primer hiperkoleszterinémia (heterozigóta famailiáris és nem-familiáris) vagy kevert diszlipidémia ateroszklerotikus kardiovaszkuláris betegségben, high LDL-cholesterol level magas LDL-koleszterinszint, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
EItoCVP, NCT06338293: Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques |
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| Not yet recruiting | 4 | 40 | NA | Inclisiran sodium, Rosuvastatin | Nanjing First Hospital, Nanjing Medical University | Coronary Artery Disease | 12/24 | 05/25 | | |
ARTCAP, NCT06280976: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) |
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| Recruiting | 4 | 200 | US | Statin, atorvastatin, Aspirin tablet, aspirin 81 mg, Nexlizet, bempedoic acid-ezetimibe, LEQVIO, inclisiran, Vascepa, icosapent ethyl, Jardiance, empagliflozin, Colchicine | University of Louisville | Coronary Artery Disease, Atherosclerosis, Heart Attack | 01/29 | 01/29 | | |
CAPRICI, NCT06421363: Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease |
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| Not yet recruiting | 4 | 50 | Europe | Inclisiran | Jose Seijas Amigo | Ischemic Heart Disease, Acute Coronary Syndrome | 06/25 | 08/27 | | |
NCT06431763: A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease. |
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| Recruiting | 4 | 400 | Europe | Inclisiran sodium, PCSK9 inhibitor, siRNA, BPA, small molecule, ACL inhibitor | Novartis Pharmaceuticals | Hypercholesterolemia | 09/25 | 09/25 | | |
V-ACCELERATE, NCT06372925: Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction |
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| Not yet recruiting | 4 | 318 | NA | atorvastatin, IVUS/OCT, inclisiran | Novartis Pharmaceuticals | Plaque, Atherosclerotic | 06/26 | 06/26 | | |
V-INCLUSION, NCT06249165: VictORION-INCLUSION is a Multicenter, Randomized, Open Label, Study of Inclisiran + Usual Care vs Usual Care Alone in an Inclusive and Underrepresented Population at High Risk for or Diagnosed With ASCVD Within a Pragmatic EHR Framework. |
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| Not yet recruiting | 4 | 1440 | NA | Inclisiran | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 06/26 | 11/26 | | |
NCT06386419: A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia |
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| Not yet recruiting | 4 | 65 | NA | inclisiran, KJX839 | Novartis Pharmaceuticals | Primary Hypercholesterolemia, Mixed Dyslipidemia | 08/25 | 08/25 | | |
| Recruiting | 4 | 600 | RoW | Inclisiran Prefilled Syringe, LEQVIO, SMS messages, Monthly Text Messages, Telephone-based support calls, Nurse Support Calls | Monash University, Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease (ASCVD), Coronary Heart Disease (CHD), Cerebrovascular Disease, Peripheral Arterial Disease (PAD) | 06/24 | 06/25 | | |
V-DIFFERENCE, NCT05192941 / 2021-003759-40: Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia |
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| Active, not recruiting | 4 | 1775 | Europe, RoW | Inclisiran Sodium, KJX839, Placebo | Novartis Pharmaceuticals, Novartis Pharma AG | Hypercholesterolemia | 06/24 | 03/25 | | |
