Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-19 @ 12:04 AM
Study NCT ID:
NCT07214857
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2025-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2025-10-06', 'studyFirstSubmitQcDate': '2025-10-06', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Number of US Patients Eligible for Inclisiran Treatment', 'timeFrame': '10 years'}, {'measure': 'Estimated Number of Preventable Cardiovascular Events Over 10-years of Inclisiran Treatment', 'timeFrame': '10 years'}]}, 'conditionsModule': {'keywords': ['Prevention', 'Inclisiran', 'Statins', 'Diabetes'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to estimate the number of United States (US) adults with and without prior atherosclerotic cardiovascular disease (ASCVD) and diabetes who may be eligible for inclisiran based on US National Health and Nutrition Examination Survey (NHANES) data and inclisiran eligibility criteria from ongoing clinical trials as well as to estimate the number of preventable ASCVD events based on expected risk reductions from the degree of low-density lipoprotein cholesterol (LDL-C) lowering expected from inclisiran.\n\nThis study used data from the US NHANES 2011-2020 surveys. NHANES is a national survey which collects medical history, laboratory, and medication information from participants of all ages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This was a cross-sectional, non-interventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Aged 18 years of age or older\n* Elevated LDL-C despite statin therapy\n* Other inclusion criteria per ongoing inclisiran clinical trials'}, 'identificationModule': {'nctId': 'NCT07214857', 'briefTitle': 'Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States', 'orgStudyIdInfo': {'id': 'CKJX839D1US03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Secondary Prevention Population', 'description': 'Patients with known ASCVD who met the secondary prevention population eligibility criteria.'}, {'label': 'High-risk Primary Prevention Population', 'description': 'Patients without known ASCVD who met the high-risk primary prevention population eligibility criteria.'}, {'label': 'Diabetes Population', 'description': 'Patients with diabetes who met the diabetes population eligibility criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}