Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT05783804
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '40 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CAD Progression', 'timeFrame': '40 Weeks', 'description': 'Difference in total plaque volume between the initial and follow-up CCTA scan'}], 'secondaryOutcomes': [{'measure': 'Non-calcified plaque progression', 'timeFrame': '40 Weeks', 'description': 'Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan'}, {'measure': 'Calcified plaque progression', 'timeFrame': '40 Weeks', 'description': 'Difference in calcified plaque volume between the baseline and follow-up CCTA scan'}, {'measure': 'Number of high-risk plaques', 'timeFrame': '40 Weeks', 'description': 'Difference in number of high-risk plaques between the baseline and follow-up CCTA scan'}, {'measure': 'Difference in Pericoronary Adipose Tissue Attenuation', 'timeFrame': '40 Weeks', 'description': 'Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease Progression']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, intensive lipid lowering therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (newly diagnosed) heterozygous FH patients between 18 and 50 years with non-calcificated plaque on coronary CT angiography and who are not optimally treated yet.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with heterozygous familial hypercholesterolemia\n* Adult between 18 and 50 years old\n* LDL cholesterol levels above 100 mg/dl (\\>2.6 mmol/L) at inclusion\n\nExclusion Criteria:\n\n* Renal insufficiency, defined as eGFR \\< 30 ml/min\n* History of atherosclerotic cardiovascular events\n* Atrial fibrillation\n* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator\n* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.'}, 'identificationModule': {'nctId': 'NCT05783804', 'acronym': 'EAGLE', 'briefTitle': 'Plaque Reversal With Early, Aggressive Lipid Lowering Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Plaque Reversal With Early, Aggressive Lipid Lowering Therapy', 'orgStudyIdInfo': {'id': 'NL75337.018.20'}}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Erik S. G. Stroes, MD, PhD', 'role': 'CONTACT', 'email': 'e.s.stroes@amsterdamumc.nl', 'phone': '+31205669111'}], 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Erik SG Stroes, MD, PhD', 'role': 'CONTACT', 'email': 'e.s.stroes@amsterdamumc.nl', 'phone': '+205669111'}], 'overallOfficials': [{'name': 'Erik SG Stroes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location AMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. E.S.G. Stroes, MD, PhD.', 'investigatorFullName': 'E.S.stroes', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}