| Leqvio (inclisiran) / Novartis |
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] | | | | |
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 | | |
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 | | |
| 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 | | |
2017-005066-22: A research study to find out whether inclisiran sodium, given as injection under the skin every 6 months for about 5 years, helps to prevent heart attacks, strokes or the need for urgent procedures to unblock the arteries supplying the heart, in people who already have vascular disease. |
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| Not yet recruiting | 3 | 15000 | Europe | Inclisiran for Injection, Inclisiran for Injection, Solution for injection | University of Oxford, The Medicines Company, , The Medicines Company | Atherosclerotic cardiovascular disease, Circulatory problems (such as heart attacks and strokes) caused by narrowing of the vessels supplying blood to the brain, heart and other organs, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2021-002006-27: A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease. Une étude de recherche visant à déterminer si un médicament appelé inclisiran aide à prévenir les décès cardiovasculaires, les crises cardiaques ou les accidents vasculaires cérébraux chez les personnes qui souffrent déjà d'une maladie vasculaire. |
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| Ongoing | 3 | 15000 | Europe, RoW | Inclisiran sodium, KJX839, Solution for injection in pre-filled syringe, Leqvio 284 mg solution for injection in pre-filled syringe | Novartis Pharma AG, NOVARTIS PHARMA AG, Novartis Pharma AG | Atherosclerotic cardiovascular disease (ASCVD) Maladie cardiovasculaire athéroscléreuse, Circulatory problems (such as heart attacks and strokes) caused by narrowing of the vessels supplying blood to the brain, heart and other organs Problèmes circulatoires (tels que les crises cardiaques et les accidents vasculaires cérébraux) causés par le rétrécissement des vaisseaux alimentant en sang le cerveau, le cœur et d'autres organes, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2021-004601-47: Coronary computed tomography study to assess the effect of inclisiran on atherosclerotic plaque progression in participants with a diagnosis of nonobstructivecoronary artery disease without previous cardiovascular events --- |
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| Not yet recruiting | 3 | 600 | Europe | Inclisiran, [KJX839], Solution for injection in pre-filled syringe, Leqvio 284 mg solution for injection in pre-filled syringe | NOVARTIS PHARMA AG, Novartis Pharma AG, Novartis Farmacéutica, S.A., Novartis Pharma AG | Non-obstructive coronary artery disease -, atherosclerotic plaque (fatty deposits that can lead to heart disease) in the heart with less than 50% obstruction of blood flow -, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
NCT04765657: Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C) |
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| Active, not recruiting | 3 | 345 | RoW | inclisiran sodium, KJX839, Placebo | Novartis Pharmaceuticals | Hypercholesterolemia | 06/22 | 12/26 | | |
SPIRIT, NCT04807400: Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support |
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| Completed | 3 | 892 | Europe | Inclisiran, Behavioural Support, Background lipid lowering therapy | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol | 01/23 | 01/23 | | |
V-INITIATE, 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) |
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| Completed | 3 | 450 | US | Inclisiran, Inclisiran First | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 09/23 | 09/23 | | |
| Active, not recruiting | 3 | 160 | Europe | lerodalcibep, LIB003, Inclisiran, Leqvio | LIB Therapeutics LLC, Medpace, Inc. | Hypercholesterolemia, Atherosclerotic Ischemic Disease | 05/24 | 07/24 | | |
V-PLAQUE, NCT05360446: Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events |
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| Recruiting | 3 | 600 | Europe, Canada, Japan, US, RoW | Inclisiran sodium 300 mg, Placebo | Novartis Pharmaceuticals | Coronary Artery Disease | 01/27 | 01/27 | | |
ORION-4, NCT03705234: A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease |
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| Active, not recruiting | 3 | 16124 | Europe, US | Inclisiran, Placebo, Saline solution | University of Oxford, The TIMI Study Group, Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 07/26 | 12/49 | | |
VICTORION-2P, NCT05030428: Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease |
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| Active, not recruiting | 3 | 17006 | Europe, Canada, Japan, US, RoW | Inclisiran sodium 300 mg, Placebo | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 10/27 | 10/27 | | |
| Recruiting | 3 | 14000 | Europe, Canada, US, RoW | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, KJX839, Placebo in 1.5ml | Novartis Pharmaceuticals | Primary Prevention of Atherosclerotic Cardiovascular Disease | 04/29 | 04/29 | | |
SIRIUS, NCT05974345: In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease |
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| Completed | N/A | 204691 | Europe | Inclisiran sodium, Placebo, Ezetimibe, Evolocumab | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 12/23 | 12/23 | | |
NCT06416813: Preventive Intervention Value of Inclisiran Combined With DCB in Vulnerable Coronary Atherosclerotic Plaques |
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| Not yet recruiting | N/A | 140 | NA | GDMT+DCB | Yong He | Acute Coronary Syndrome | 06/27 | 12/27 | | |
| Recruiting | N/A | 63 | Europe | Inclisiran, 68Ga-DOTATATE PET-MRI, Colchicine | University of Cambridge, Cambridge University Hospitals NHS Foundation Trust, Wellcome Trust, GE Healthcare, Lund University | Hypercholesterolemia, Hypercholesterolemia, Familial, Atherosclerosis, Carotid Artery Plaque | 03/25 | 03/25 | | |
| Recruiting | N/A | 300 | Europe | Inclisiran | Novartis Pharmaceuticals | Atherosclerotic Cardiovascular Disease | 07/26 | 07/26 | | |
NCT05639218: Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques |
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| Active, not recruiting | N/A | 50 | Europe | Inclisiran, PCSK9 inhibitor | Pauls Stradins Clinical University Hospital | Atherosclerotic Cardiovascular Disease | 02/23 | 12/23 | | |
