Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 2:33 PM
Study NCT ID:
NCT07334834
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000465', 'term': 'Algorithms'}], 'ancestors': [{'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative Effectiveness'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The between group difference in LDL-C percent change', 'timeFrame': 'Baseline to 3 months'}], 'secondaryOutcomes': [{'measure': 'Between group difference', 'timeFrame': 'Baseline to 1 and 6 months', 'description': 'LDL-C percent change'}, {'measure': 'Between group difference', 'timeFrame': '1, 3 and 6 months', 'description': 'The proportion achieving LDL-C \\<55 mg/dL'}, {'measure': 'Between group difference', 'timeFrame': '1, 3 and 6 months', 'description': 'Proportion receiving combination lipid lowering Therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lipid Management', 'Atherosclerotic Cardiovascular Disease', 'Coronary Artery Disease', 'Peripheral Artery Disease', 'Carotid Artery Disease'], 'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, collaborative, multicenter, pilot implementation science study evaluating the hypothesis that algorithm- and multi-professional team-supported lipid management reduces low density lipoprotein-cholesterol (LDL-C) compared with usual care in patients with atherosclerotic cardiovascular disease (ASCVD).', 'detailedDescription': 'OPTIMIZE-ASCVD is a randomized, controlled, collaborative, open-label, multicenter pilot implementation science study evaluating the hypothesis that algorithm- (Appendix A) and multi-professional team-supported lipid management reduces LDL-C compared with usual care in patients with ASCVD.\n\nApproximately 100 participants will be randomized (1:1).\n\n* Participant preference for injectable vs oral lipid therapy will be recorded at baseline.\n* Participants allocated to algorithm-and multi-professional team-supported lipid management will be evaluated by a physician and prescribed lipid therapy which aims to achieve LDL-C target without titration. Participants will be contacted by a pharmacist to provide education about the medication and support any access issues.\n* Participants allocated to usual care will be referred for management by their usual care provider who will receive a summary of guideline recommendations\n\nThe study will include decentralized clinical trial features including use of local, Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for blood tests, use of data extracted from the electronic medical record (EMR), electronic collection of patient-reported outcomes (PRO) and remote conduct of study activities. As an open label study with both strategy groups receiving GDMT, no Data and Safety Monitoring Committee will be convened. Study leadership will monitor aggregate data during the trial and may modify the sample size and/or cap enrollment of subgroups to ensure consistency with design assumptions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provided informed consent\n* Age \\>18 years inclusive at screening\n* Documented atherosclerotic vascular disease including:\n\n * Coronary artery disease (prior revascularization, myocardial infarction, imaging evidence of coronary atherosclerosis)\n * Peripheral artery disease (prior revascularization, amputation, ankle: brachial index (ABI) ≤ 0.90, imaging evidence of extra-coronary atherosclerosis)\n * Carotid artery disease (prior endarterectomy or stenting of the extracranial carotid artery or imaging evidence of carotid atherosclerosis)\n * Imaging evidence of atherosclerotic vascular disease in a non-coronary vascular bed (e.g. aorta, mesenteric, renal)\n * LDL-C \\>70mg/dL\n\nExclusion Criteria:\n\n* Any reason that, in the opinion of the investigator, the patient would be unable to adhere to the protocol for the duration of the study (e.g. terminal diagnosis, metastatic cancer) or in whom participation might result in harm.\n* Planned active titration of current lipid-lowering therapy\n* Myocardial infarction or arterial revascularization within prior 30 days'}, 'identificationModule': {'nctId': 'NCT07334834', 'acronym': 'OPTIMIZE ASCVD', 'briefTitle': 'Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Colorado Prevention Center'}, 'officialTitle': 'Implementation of an Algorithm- and Multi-professional Team-supported Strategy to Improve Lipid Management of Patients With Atherosclerotic Cardiovascular Disease: OPTIMIZE ASCVD', 'orgStudyIdInfo': {'id': '202401CPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control: Guideline-directed lipid management by usual care provider', 'interventionNames': ['Other: Guideline-directed lipid management by usual care provider']}, {'type': 'EXPERIMENTAL', 'label': 'Algorithm- and multi-professional team-supported lipid management', 'interventionNames': ['Other: Algorithm- and multi-professional team-supported lipid management']}], 'interventions': [{'name': 'Algorithm- and multi-professional team-supported lipid management', 'type': 'OTHER', 'otherNames': ['Experimental'], 'description': 'Algorithm- and multi-professional team-supported lipid management', 'armGroupLabels': ['Algorithm- and multi-professional team-supported lipid management']}, {'name': 'Guideline-directed lipid management by usual care provider', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'Guideline-directed lipid management by usual care provider', 'armGroupLabels': ['Control: Guideline-directed lipid management by usual care provider']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc Bonaca, MD', 'role': 'CONTACT'}], 'facility': 'University of Colorado Health System (UCHealth)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Marc Bonaca, MD', 'role': 'CONTACT', 'email': 'info@cpcmed.org', 'phone': '(303) 860-9900'}, {'name': 'Sivan Naveh, MD. RPV', 'role': 'CONTACT', 'email': 'sivan.naveh@cpcmed.org', 'phone': '720-848-5300'}], 'overallOfficials': [{'name': 'Marc Bonaca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado Prevention Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado Prevention Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}