Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-20 @ 7:18 AM
Study NCT ID:
NCT05399992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2022-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C585830', 'term': 'ALN-PCS'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 852}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in LDL-C from baseline to 10 months', 'timeFrame': 'Baseline, 10 months', 'description': 'Percentage change in Low density lipoprotein - Cholesterol (LDL-C)'}], 'secondaryOutcomes': [{'measure': 'Percentage change in LDL-C from baseline', 'timeFrame': 'Baseline, month 4, month 16, month 22', 'description': 'Percentage change in LDL-C from baseline is collected'}, {'measure': 'Percentage change in LDL-C from baseline by ≥50%', 'timeFrame': 'Month 4, month 10, month 16, month 22', 'description': 'Percentage change in LDL-C from baseline by ≥50%'}, {'measure': 'Percentage change in LDL-C from baseline by ≥30%', 'timeFrame': 'Month 4, month 10, month 16, month 22', 'description': 'Percentage change in LDL-C from baseline by ≥30%'}, {'measure': 'Proportion of participants achieving LDL-C<55 mg/dL', 'timeFrame': 'Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22', 'description': 'Proportion of participants achieving LDL-C\\<55 mg/dL'}, {'measure': 'Proportion of participants achieving LDL-C<70 mg/dL', 'timeFrame': 'Month 4, month 10, month 16 and month 22', 'description': 'Proportion of participants achieving LDL-C\\<70 mg/dL'}, {'measure': 'Time-averaged percentage change in LDL-C from baseline', 'timeFrame': 'Baseline, month 4, month 10, month 16 and month 22', 'description': 'Time-averaged percentage change in LDL-C from baseline'}, {'measure': 'Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months', 'timeFrame': 'Month 10, month 16, month 22 and month 24', 'description': 'Proportion of participants achieving ≥50% reduction in LDL C at month 10 and maintaining this at 16, 22 and 24 months'}, {'measure': 'Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months', 'timeFrame': 'Baseline, month 10, month 24', 'description': 'Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months'}, {'measure': 'Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months', 'timeFrame': 'Month 10 and month 24', 'description': 'Proportion of participants achieving \\<55 mg/dL and \\<70 mg/dL in LDL-C at 10 months and maintaining until 24 months'}, {'measure': 'Inclisiran cohort : Percentage of days covered by inclisiran', 'timeFrame': '12 months and 24 months', 'description': 'Inclisiran cohort : Percentage of days covered by inclisiran'}, {'measure': 'Inclisiran cohort : Mean PDC', 'timeFrame': '12 months and 24 months', 'description': 'Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected'}, {'measure': 'Inclisiran cohort : Proportion of participants with a PDC ≥ 80%', 'timeFrame': '12 months and 24 months', 'description': 'Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)'}, {'measure': 'Proportion of participants remaining on initial baseline therapy', 'timeFrame': 'Baseline, month 12 and month 24', 'description': 'Proportion of patients remaining on initial baseline therapy in the inclisiran cohort'}, {'measure': 'Time to discontinuation of any newly initiated therapies', 'timeFrame': 'Month 12 and month 24', 'description': 'Time to discontinuation of any newly initiated therapies'}, {'measure': 'Time to discontinuation of any newly initiated therapies by specific LLT', 'timeFrame': 'Month 12 and month 24', 'description': 'Time to discontinuation of any newly initiated therapies by specific LLT'}, {'measure': 'Change from baseline in scores from the TSQM (modified) instrument', 'timeFrame': 'Baseline, month 12 and month 24', 'description': "The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction.\n\nTSQM V1.4 has a score range of 0 to 100 with with higher scores indicating higher patient satisfaction with medication."}, {'measure': 'Descriptive adherence data based on Adherence AAQ', 'timeFrame': 'Month 12 and month 24', 'description': 'Adherence Assessment Questionnaires (AAQ) measures the degree of identified non-adherence to LLT therapy.\n\nAAQ has a score range from 0 (not adherent at all) to 100 (absolute adherent).'}, {'measure': 'Descriptive adherence data based on ABQ', 'timeFrame': 'Month 12 and month 24', 'description': 'Adherence Barriers Questionnaire (ABQ) is an instrument for identifying specific barriers to medication-related adherence.\n\nABQ is a descriptive analysis. The number and proportion of patients affected by each barrier will be reported for inclisiran participants.'}]}, 'conditionsModule': {'keywords': ['primary hypercholesterolemia', 'mixed dyslipidemia', 'real-world study', 'inclisiran', 'lipid-lowering therapy', 'LLT', 'ASCVD'], 'conditions': ['Primary Hypercholesterolemia', 'Mixed Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.', 'detailedDescription': 'Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants who are 18 years or older\n2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH\n3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines\n4. Participants who per physician's criteria need to optimize their LLT\n5. Participants who provide written informed consent to participate in the study\n6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.\n\nExclusion Criteria:\n\n1. Participants that have received inclisiran previously\n2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)"}, 'identificationModule': {'nctId': 'NCT05399992', 'acronym': 'VICTORION REAL', 'briefTitle': 'Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'VICTORION REAL: An International Prospective Real-world Study to Evaluate the LDL-C changE and Adherence to incLisiran in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia', 'orgStudyIdInfo': {'id': 'CKJX839A12401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inclisiran cohort', 'description': 'Participants prescribed inclisiran alone or with other LLTs as per approved label', 'interventionNames': ['Other: Inclisiran']}], 'interventions': [{'name': 'Inclisiran', 'type': 'OTHER', 'description': 'Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.', 'armGroupLabels': ['Inclisiran cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6807', 'city': 'Feldkirch', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5621', 'city': 'Sankt Veit im Pongau', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.33333, 'lon': 13.15}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1180', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis 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