Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 5:29 AM
Study NCT ID:
NCT04873934
Status:
COMPLETED
Last Update Posted:
2025-10-16
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585830', 'term': 'ALN-PCS'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 330 days.', 'description': 'All safety analyses were conducted in the Safety Set.', 'eventGroups': [{'id': 'EG000', 'title': 'Inclisiran + Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 52, 'seriousNumAtRisk': 203, 'deathsNumAffected': 0, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Usual Care Alone', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 35, 'seriousNumAtRisk': 197, 'deathsNumAffected': 2, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cardiac perfusion defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Heart failure with preserved ejection fraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blindness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Muscle abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'categories': [{'measurements': [{'value': '-10.4', 'groupId': 'OG000', 'lowerLimit': '-25.9', 'upperLimit': '5.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '-9.7', 'upperLimit': '21.6'}]}]}, {'title': 'HDL-Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '17.3'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '13.9'}]}]}, {'title': 'triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '14.4'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '19.6'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.5', 'ciLowerLimit': '-44.8', 'ciUpperLimit': '-30.3', 'groupDescription': 'Apolipoprotein B', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.4', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '3.1', 'groupDescription': 'VLDL Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.7', 'ciLowerLimit': '-44.0', 'ciUpperLimit': '-31.4', 'groupDescription': 'Non-HDL Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.5', 'ciLowerLimit': '-30.2', 'ciUpperLimit': '-20.7', 'groupDescription': 'Total Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.4', 'ciLowerLimit': '-38.4', 'ciUpperLimit': '5.7', 'groupDescription': 'Lipoprotein(a)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '8.1', 'groupDescription': 'HDL Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.339', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.0', 'ciLowerLimit': '-15.2', 'ciUpperLimit': '5.3', 'groupDescription': 'Triglycerides', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 330', 'description': 'Percent change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, lipoprotein(a) (Lp\\[a\\]), HDL-C and triglycerides from baseline to Day 330', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran With Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care Alone'}], 'classes': [{'title': 'apolipoprotein B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.0', 'groupId': 'OG000', 'lowerLimit': '-34.2', 'upperLimit': '-27.8'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-5.8', 'upperLimit': '0.6'}]}]}, {'title': 'VLDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '1.3'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.5'}]}]}, {'title': 'non-HDL-Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-41.4', 'groupId': 'OG000', 'lowerLimit': '-46.5', 'upperLimit': '-36.3'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '4.0'}]}]}, {'title': 'total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.2', 'groupId': 'OG000', 'lowerLimit': '-40.5', 'upperLimit': '-30.0'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '7.9'}]}]}, {'title': 'HDL-Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '7.1'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '5.3'}]}]}, {'title': 'triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-8.7', 'upperLimit': '10.8'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '19.9'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.4', 'ciLowerLimit': '-33.0', 'ciUpperLimit': '-23.9', 'groupDescription': 'Apolipoprotein B', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '0.2', 'groupDescription': 'VLDL Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.1', 'ciLowerLimit': '-47.5', 'ciUpperLimit': '-32.8', 'groupDescription': 'Non-HDL Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.7', 'ciLowerLimit': '-45.3', 'ciUpperLimit': '-30.2', 'groupDescription': 'Total Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.065', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '3.8', 'groupDescription': 'HDL Cholesterol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.7', 'ciLowerLimit': '-22.8', 'ciUpperLimit': '5.3', 'groupDescription': 'Triglycerides', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 330', 'description': 'Absolute change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, HDL-C and triglycerides from baseline to Day 330', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Lp[a] From Baseline to Day 330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran With Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.3', 'groupId': 'OG000', 'lowerLimit': '-26.2', 'upperLimit': '-12.4'}, {'value': '-5.3', 'groupId': 'OG001', 'lowerLimit': '-12.2', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.0', 'ciLowerLimit': '-23.8', 'ciUpperLimit': '-4.2', 'groupDescription': 'Lipoprotein(a)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 330', 'description': 'Absolute change in lipoprotein(a) (Lp\\[a\\]) from baseline to Day 330', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330.'}, {'type': 'SECONDARY', 'title': 'Intensity of Lipid Lowering Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran With Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care Alone'}], 'classes': [{'title': 'Decrease in statin intensity', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '15.0'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '8.9'}]}]}, {'title': 'No change in statin intensity', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '83.7', 'upperLimit': '93.2'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '87.6', 'upperLimit': '96.0'}]}]}, {'title': 'Increase in statin intensity', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.9'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '6.6'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.93', 'statisticalMethod': 'proportional odds model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 330', 'description': 'Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had a record for Day 330 study visit date.'}, {'type': 'SECONDARY', 'title': 'Proportion of Days Covered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran With Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0.926', 'groupId': 'OG000', 'lowerLimit': '0.900', 'upperLimit': '0.953'}, {'value': '0.965', 'groupId': 'OG001', 'lowerLimit': '0.939', 'upperLimit': '0.992'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.039', 'ciLowerLimit': '-0.077', 'ciUpperLimit': '-0.001', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through last date of participation, up to 330 Days', 'description': 'Total number of days on either statin, ezetimibe, or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days. If a participant did not take any of the 3 medications, then the total number of days was assumed to be zero.', 'unitOfMeasure': 'Proportion of days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) comprised all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Discontinuation of Statin Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inclisiran With Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual Care Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '19.7'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '23.6'}]}]}], 'analyses': [{'pValue': '0.346', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.35', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 330', 'description': 'Percentage of participants discontinuing statin therapy. Discontinuation of statin therapy was defined as no statin use ≥ 30 days before the end-of-study visit.\n\nParticipants for whom it could not be ascertained that they were on statin therapy at the end of study or who discontinued from the study early were assumed to have discontinued statin therapy.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) comprised all randomized participants. Participants with Medical History of Statin Intolerance were excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inclisiran With Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Usual Care Alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'Full Analysis Set', 'comment': 'Full Analysis Set (FAS) included all randomized participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'Safety Set', 'comment': 'Safety Set included all participants who received study treatment. Participants in the usual care treatment group who had data collected at the baseline visit were included in the Safety Set.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '197'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 87 study centers. Of the 201 participants randomized to inclisiran + usual care, 1 participant was randomized erroneously and did not receive inclisiran. Of the 199 participants randomized to usual care, 3 participants received commercially available inclisiran as part of their concomitant medications.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inclisiran With Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Usual Care Alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '10.90', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '11.69', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '11.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-20', 'size': 2582427, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-01T04:46', 'hasProtocol': True}, {'date': '2024-08-29', 'size': 2102111, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-01T04:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2021-04-30', 'resultsFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-01', 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Day 330 in LDL-C', 'timeFrame': 'Baseline and Day 330', 'description': 'Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330'}, {'measure': 'Achievement of LDL-C < 70 mg/dL at Day 330', 'timeFrame': 'Day 330', 'description': 'Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) \\< 70 mg/dL at Day 330'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in LDL-C', 'timeFrame': 'Baseline, Day 90, Day 270 and Day 330', 'description': 'Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit'}, {'measure': 'Average Percent Change From Baseline in LDL-C Levels', 'timeFrame': 'Baseline, from Day 90 to Day 330', 'description': 'Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit'}, {'measure': 'Average Absolute Change From Baseline in LDL-C Levels', 'timeFrame': 'Baseline, From Day 90 to Day 330', 'description': 'Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit'}, {'measure': 'Achieving ≥50% Reduction From Baseline in LDL-C', 'timeFrame': 'Baseline, Day 330', 'description': 'Percentage of participants achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 330'}, {'measure': 'Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL', 'timeFrame': 'Day 330', 'description': 'Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) \\<100 mg/dL (among the subset of participants with baseline LDL-C \\>= 100 mg/dL) and LDL-C \\< 55 mg/dL at Day 330'}, {'measure': 'Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330', 'timeFrame': 'Baseline and Day 330', 'description': 'Percent change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, lipoprotein(a) (Lp\\[a\\]), HDL-C and triglycerides from baseline to Day 330'}, {'measure': 'Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330', 'timeFrame': 'Baseline and Day 330', 'description': 'Absolute change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, HDL-C and triglycerides from baseline to Day 330'}, {'measure': 'Absolute Change in Lp[a] From Baseline to Day 330', 'timeFrame': 'Baseline and Day 330', 'description': 'Absolute change in lipoprotein(a) (Lp\\[a\\]) from baseline to Day 330'}, {'measure': 'Intensity of Lipid Lowering Therapy', 'timeFrame': 'Baseline and Day 330', 'description': 'Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change)'}, {'measure': 'Proportion of Days Covered', 'timeFrame': 'Baseline through last date of participation, up to 330 Days', 'description': 'Total number of days on either statin, ezetimibe, or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days. If a participant did not take any of the 3 medications, then the total number of days was assumed to be zero.'}, {'measure': 'Discontinuation of Statin Therapy', 'timeFrame': 'Baseline and Day 330', 'description': 'Percentage of participants discontinuing statin therapy. Discontinuation of statin therapy was defined as no statin use ≥ 30 days before the end-of-study visit.\n\nParticipants for whom it could not be ascertained that they were on statin therapy at the end of study or who discontinued from the study early were assumed to have discontinued statin therapy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperlipidemia', 'Atherosclerotic Cardiovascular Disease', 'Hypercholesterolemia', 'Lipid lowering therapies'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2749', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.', 'detailedDescription': 'This was a randomized, parallel-group, open-label, multicenter, 1-year (30-day Screening Period and 330-day Treatment Period) study comparing an LDL-C management strategy including inclisiran + usual care to usual care alone. Approximately 384 participants were planned to be randomized 1:1 to aggressive LDL-C management with inclisiran + usual care (intervention arm) (3 inclisiran doses) or usual care (control arm). Usual care could have included addition of ezetimibe, bempedoic acid, PCSK9-inhibiting monoclonal antibodies, and/or commercially available inclisiran'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening\n* Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL\n* Fasting triglycerides \\<4.52 mmol/L (\\<400 mg/dL) at screening\n* Calculated glomerular filtration rate \\>20 mL/min by estimated glomerular filtration rate (eGFR)\n* Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction \\<25%.\n* Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.\n* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.\n* Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer.\n* Planned use of other investigational products or devices during the course of the study.\n* Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.\n* Recurrent ACS event within 2 weeks prior to randomization.\n* Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.'}, 'identificationModule': {'nctId': 'NCT04873934', 'acronym': 'V-INCEPTION', 'briefTitle': 'Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome (VICTORION-INCEPTION)', 'orgStudyIdInfo': {'id': 'CKJX839A1US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inclisiran with Usual Care', 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)', 'interventionNames': ['Drug: Inclisiran']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual Care Alone'}], 'interventions': [{'name': 'Inclisiran', 'type': 'DRUG', 'otherNames': ['KJX839'], 'description': 'Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)', 'armGroupLabels': ['Inclisiran with Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northeast Arkansas Baptist Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '93308', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Central Cardiology Medical Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'The Heart Group Cardiovascular Associates Inc', 'geoPoint': {'lat': 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'facility': 'Tidal Health Peninsula Regional Inc', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Clincal Research Institute', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48640', 'city': 'Midland', 'state': 'Michigan', 'country': 'United States', 'facility': 'MidMichigan Physicians Group', 'geoPoint': {'lat': 43.61558, 'lon': -84.24721}}, {'zip': '48601', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'St Marys of Ascension Research', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Trinity Health Michigan Heart', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': 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'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Heart Care, LLC', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'zip': '08318', 'city': 'Elmer', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cardiovas Assoc of Delaware Valley', 'geoPoint': {'lat': 39.59511, 'lon': -75.17018}}, {'zip': '08062', 'city': 'Mullica Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Inspira Medical Cent Mullica Hill', 'geoPoint': {'lat': 39.73928, 'lon': -75.22407}}, {'zip': '12211', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Capital Cardiology Associates', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University At Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '13326', 'city': 'Cooperstown', 'state': 'New York', 'country': 'United States', 'facility': 'Bassett Medical Center', 'geoPoint': {'lat': 42.70048, 'lon': -74.92426}}, {'zip': '11418', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Jamaica Hospital Medical Center', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11422', 'city': 'Rosedale', 'state': 'New York', 'country': 'United States', 'facility': 'Laurelton Heart Specialist PC', 'geoPoint': {'lat': 40.66205, 'lon': -73.73541}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cary Research Group', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United 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'country': 'United States', 'facility': 'Guthrie Clinic', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Monument Health Clinical Research', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37916', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Covenant Medical Group', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott and White Heart and Vascular Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77017', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Vilo Research Group LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart Medical Group', 'geoPoint': {'lat': 29.76328, 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'facility': 'Research Group of North Texas', 'geoPoint': {'lat': 32.79652, 'lon': -96.56082}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cardiovascular Consultants', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '23608', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'TPMG Clinical Research', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23504', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'York Clinical Research', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Dominion Medical Associates', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '24013', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Clinic', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Selma Medical Associates', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Institute for Research and Innovation', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}