Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-02 @ 2:41 AM
Study NCT ID:
NCT05629767
Status:
TERMINATED
Last Update Posted:
2024-02-13
First Post:
2022-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracking of Lipid Lowering Therapy in Jordan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-06', 'size': 321579, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-13T03:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Inadequate enrolling numbers of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-10', 'studyFirstSubmitDate': '2022-10-29', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achieving a target LDL-C bloob level of 70 mg/dl or less', 'timeFrame': '12 months', 'description': 'At 1 year of follow up, all participants will have their blood lipid profile measured to examine the frequency of attaining an LDL-C level of 70 mg/dl or less'}, {'measure': 'Modifying the dose and class of lipid-lowering therapy', 'timeFrame': '12 months', 'description': 'Up titrating the dose of the same lipid-lowering agent or adding new agent during the study period of 12 months. Agents available include statins, ezetimibe and PCSK9 inhibitors.'}, {'measure': 'Clinical cardiovascular events', 'timeFrame': '12 months', 'description': 'The study will study the frequency of incident acute cardiovascular the participating individuals experienced. Such events include cardiovascular death, acute coronary syndrome, stroke, lower extremity acute arterial insufficiency, and arterial revascularization procedure (coronary and other arterial beds).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low-density lipoprotein cholesterol (LDL-C), Target levels'], 'conditions': ['Dyslipidemias', 'Atherosclerotic Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '27602082', 'type': 'RESULT', 'citation': 'Shi A, Tao Z, Wei P, Zhao J. Epidemiological aspects of heart diseases. Exp Ther Med. 2016 Sep;12(3):1645-1650. doi: 10.3892/etm.2016.3541. Epub 2016 Jul 26.'}, {'pmid': '24239923', 'type': 'RESULT', 'citation': 'Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.'}, {'pmid': '30423394', 'type': 'RESULT', 'citation': 'Wilson PWF, Polonsky TS, Miedema MD, Khera A, Kosinski AS, Kuvin JT. Systematic Review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):3210-3227. doi: 10.1016/j.jacc.2018.11.004. Epub 2018 Nov 10.'}, {'pmid': '16110718', 'type': 'RESULT', 'citation': 'Bloom BS. Effects of continuing medical education on improving physician clinical care and patient health: a review of systematic reviews. Int J Technol Assess Health Care. 2005 Summer;21(3):380-5. doi: 10.1017/s026646230505049x.'}, {'pmid': '33995586', 'type': 'RESULT', 'citation': 'Santi RL, Martinez F, Baranchuk A, Liprandi AS, Piskorz D, Lorenzatti A, Santi MPL, Kaski JC. Management of Dyslipidaemia in Real-world Clinical Practice: Rationale and Design of the VIPFARMA ISCP Project. Eur Cardiol. 2021 Apr 27;16:e16. doi: 10.15420/ecr.2020.42. eCollection 2021 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to examine the clinical practice of modifying the dose of lipid-lowering therapy in patients with atherosclerotic cardiovascular disease (ASCVD), who have LDL-C \\> 70 mg/dl despite statin treatment.', 'detailedDescription': "ASCVD is the leading cause of morbidity and mortality worldwide, in the Middle East and in Jordan. One of the major risk factors that contribute to the development and progression of ASCAD is dyslipidemia. A large number of clinical trials have reported the benefits of lowering LDL-C, in reducing the mortality rate among ASCAD patients.\n\nThe 2019 ACC/AHA blood cholesterol treatment guideline to reduce atherosclerotic cardiovascular risk in adults has expanded the role of LDL-C targets and reiterated the importance of achieving an LDL-C level of 70 mg/dl or less for patients who have ASCVD.\n\nPatients on statins and other lipid-lowering therapy in Jordan have not been tracked in the past for the potential of up escalating the lipid-lowering therapy to reach the LDL-C target.\n\nThe investigation will enroll patients with ASCVD who have LAL-C \\>70 mg/dl on lipid-lowering therapy and follow them for 12 months to examine the treating physicians' action in up-titrating the lipid-lowering therapy dose(s) and the frequency of measuring serum lipids during the study period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will enroll adults aged 18 years or old with a diagnosis of atherosclerotic cardiovascular disease on lipid-lowering therapy (statins and non-statins) and an LDL-C \\> 70mg/dl. and follow them up for 12 months to evaluate the up-titrating of the lipid-lowering therapy and the frequency of repeating the lipid measurement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Adults aged 18 years or old.\n2. Presence of atherosclerotic cardiovascular disease on lipid-lowering therapy.\n3. LDL-C \\> 70mg/dl.\n4. Willingness to sign an informed consent.\n\nExclusion criteria\n\n1. Life-threatening disease with limited survival.\n2. Unwillingness to sign an informed consent.'}, 'identificationModule': {'nctId': 'NCT05629767', 'acronym': 'JoLLA', 'briefTitle': 'Tracking of Lipid Lowering Therapy in Jordan', 'organization': {'class': 'OTHER', 'fullName': 'Jordan Collaborating Cardiology Group'}, 'officialTitle': 'Tracking Lipid-Lowering Therapy Over One Year in Middle Eastern Patients With ASCVD. The Jordan LLA Tracking Study', 'orgStudyIdInfo': {'id': 'JCCG.JoLLA.10.2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ASCVD', 'description': 'Patients with ASCVD on statins and LDL-C more than 70 mg/dl'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11184', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Istishari Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'city': 'Amman', 'country': 'Jordan', 'facility': 'Abdali Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Ayman Hammoudeh, MD FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istishari Hospital, Amman, Jordan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan Collaborating Cardiology Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}