Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT07232069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis (PRE-EMPT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV.', 'timeFrame': '2 years', 'description': 'Plaque volume in mm3 in each group'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Drug Discontinuation', 'timeFrame': 'Up to 2 years', 'description': 'Drug Tolerability outcome'}, {'measure': 'Overall drug treatment adherence', 'timeFrame': 'Up to 2 years', 'description': 'Number of days on study drugs'}, {'measure': 'Safety events of special interest', 'timeFrame': 'Up to 2 years', 'description': 'Number of safety events of special interest per group'}, {'measure': 'Total plaque volume', 'timeFrame': 'Up to 2 years', 'description': 'Plaque volume in mm3 per group'}, {'measure': 'Low-attenuation plaque volume', 'timeFrame': 'Up to 2 years', 'description': 'Low attenuated plaque volume in mm3 per group'}, {'measure': 'Calcified plaque volume', 'timeFrame': 'Up to 2 years', 'description': 'Calcified plaque volume in mm3 per group'}, {'measure': 'Number of participants with stenosis', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants with stenosis per group'}, {'measure': 'Segment involvement score', 'timeFrame': 'Up to 2 years', 'description': 'Average score per group'}, {'measure': 'Number of participants with qualitative calcified, partially calcified and non-calcified plaque composition', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants with each plaque composition description per group'}, {'measure': 'Number of participants with High-risk plaque features (positive remodeling, spotty calcium, napkin ring sign)', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants with each plaque feature (high-risk) per group'}, {'measure': 'Change in LDL-C (low-density lipoprotein cholesterol)', 'timeFrame': 'Baseline to 2 years'}, {'measure': 'Change in non-HDL-C (high-density lipoprotein cholesterol)', 'timeFrame': 'Baseline to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevention', 'Heart Disease Prevention', 'Family History of Heart Disease', 'At risk for heart disease', 'coronary artery calcium', 'non-calcified coronary plaque'], 'conditions': ['Coronary Artery Disease Risk Factors Multiple', 'Coronary Artery Disease Progression', 'Prevention & Control', 'Premature Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works.\n\nPRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called "plaque", in their heart arteries. It consists of two phases:\n\n1. A Screening Study - Participants will be assessed for plaque by one or both of these scans.\n\n * Coronary Artery Calcium (CAC) Scan: A CT scan that looks for calcium or plaque in heart arteries.\n * Coronary CT Angiography (CCTA) Scan: A CT scan that uses contrast dye to create detailed 3D pictures of heart arteries to look for plaque.\n2. A Treatment Trial (approximately 1,500 participants) - Based on the results of the CCTA, participants may be randomized into a two-year trial to test medications aimed at reducing or stabilizing plaque. Participants will have a 1 in 4 chance of receiving only placebo, and a 3 in 4 chance of receiving at least one active medication. Participants will take two pills once a day-either both active medications, one active and one placebo, or both placebos.\n\n * Rosuvastatin 20 mg: a cholesterol-lowering medicine\n * Colchicine 0.5 mg: a medication that lowers inflammation\n\nEveryone in the trial will be given information and advice on heart-healthy diet and lifestyle.\n\nParticipants will have up to two in-person visits for the screening study, then phone visits for the Treatment Trial at the beginning, 3 months, 12 months and 24 months when they will also have an in-person visit for a CCTA Scan. Participants will have blood drawn using an at-home collection device mailed to their home at the beginning, 3 months, and end of the study.', 'detailedDescription': "The PRE-EMPT trial will be a 2x2 factorial, double-masked, placebo-controlled randomized trial of the effects of high-intensity statin and low-dose colchicine, alone and in combination, on CCTA-defined Non-Calcified Coronary Plaque (NCCP) volume at 2 years. Participants found through the screening study with CAC 1-99, or through the known plaque pathway, will be eligible for the trial if they have NCCP without severe stenosis or any other exclusion criteria. Study drug will be delivered directly to participants' homes, lab samples will be self-collected at home, and all study visits will be virtual except the imaging visits (up to 3 over 2 years). The only in-person study activities will be the CAC, if applicable, and CCTA at baseline and 2 years. The investigators anticipate that this approach will be attractive to middle-aged, busy individuals who are otherwise healthy and asymptomatic. Importantly, all participants in PRE-EMPT will receive an mHealth lifestyle intervention designed to support behavioral modification, ensuring that all individuals benefit from evidence-based strategies for cardiovascular risk reduction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'Women aged 40-60 years old, Men aged 30-50 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged 40-60 years; Men aged 30-50 years\n2. Willing and able to provide informed consent and comply with study procedures\n3. Smart phone user\n4. Use of highly effective contraception by females with reproductive potential.\n5. CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\\<100 if known; elevated CAC on baseline CCTA is not exclusionary in the known plaque arm)\n6. Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab\n\nExclusion Criteria:\n\n1. 1\\. Clinical diagnosis of ASCVD Diagnosis (MI, stroke, arterial revascularization) or current symptoms thought to be from coronary artery disease\n2. PREVENT ASCVD 10-year risk \\>5% (if known)\n3. Diabetes Mellitus (DM) as defined by any of the following: new DM diagnosis in the medical record, new anti-diabetic medication, or HbA1C of 6.5% or greater. (if known)\n4. LDL-C ≥190mg/dL (most recent, if known)\n5. HIV (if known)\n6. Severe liver disease or Hepatitis C infection (if known)\n7. Pregnancy, lactation or intending to become pregnant during the study period of 2 years\n8. eGFR \\<45mL/min/1.73m2 (if known)\n9. BMI\\>40kg/m2\n10. Allergy to iodinated intravenous contrast or other contraindication to CCTA\n11. Current or previous use of lipid lowering therapy or anti-inflammatory therapy, including colchicine\n12. Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.\n13. PREVENT ASCVD 10-year risk ≥5%\n14. eGFR \\<45 ml/min/1.73m2 per baseline labs\n15. Hemoglobin A1c ≥6.5% per baseline labs\n16. LDL-C ≥190mg/dL per baseline labs\n17. Severe proximal coronary artery stenosis as determined by the central core lab\n18. Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)'}, 'identificationModule': {'nctId': 'NCT07232069', 'acronym': 'PRE-EMPT', 'briefTitle': 'Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis (PRE-EMPT)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis', 'orgStudyIdInfo': {'id': 'Pro00118744'}, 'secondaryIdInfos': [{'id': 'UG3HL181434', 'link': 'https://reporter.nih.gov/quickSearch/UG3HL181434', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rosuvastatin 20mg plus colchicine-matched placebo', 'description': 'statin plus placebo (two pills once daily)', 'interventionNames': ['Drug: Rosuvastatin 20 Mg Oral Tablet', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'colchicine 0.5mg plus rosuvastatin-matched placebo', 'description': 'anti-inflammatory plus placebo (two pills once daily)', 'interventionNames': ['Drug: Colchicine 0.5 MG Oral Tablet Once Daily', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'rosuvastatin 20mg plus colchicine 0.5mg', 'description': 'statin plus anti-inflammatory (two pills once daily)', 'interventionNames': ['Drug: Rosuvastatin 20 Mg Oral Tablet', 'Drug: Colchicine 0.5 MG Oral Tablet Once Daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo plus placebo', 'description': 'Placebo and placebo (two pills once daily)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rosuvastatin 20 Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'Statin', 'armGroupLabels': ['rosuvastatin 20mg plus colchicine 0.5mg', 'rosuvastatin 20mg plus colchicine-matched placebo']}, {'name': 'Colchicine 0.5 MG Oral Tablet Once Daily', 'type': 'DRUG', 'otherNames': ['Lodoco'], 'description': 'Anti-inflammatory', 'armGroupLabels': ['colchicine 0.5mg plus rosuvastatin-matched placebo', 'rosuvastatin 20mg plus colchicine 0.5mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, non-active, drug-matched', 'armGroupLabels': ['colchicine 0.5mg plus rosuvastatin-matched placebo', 'placebo plus placebo', 'rosuvastatin 20mg plus colchicine-matched placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'PRE-EMPT Email', 'role': 'CONTACT', 'email': 'PREEMPT@duke.edu', 'phone': '919-309-5544'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}