Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-27 @ 1:52 PM
Study NCT ID:
NCT00235950
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2005-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], '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': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-18', 'studyFirstSubmitDate': '2005-10-07', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin'}], 'secondaryOutcomes': [{'measure': 'Compare the impact of treatment with rosuvastatin to that of atorvastatin and simvastatin on clopidogrel initiated inhibition of platelet aggregation in a subset of subjects recruited in the Stockholm region.'}, {'measure': 'Compare the impact of treatment with rosuvastatin to that of atorvastatin on clopidogrel initiated inhibition of platelet aggregation in all subjects, totally and on each dose of rosuvastatin and atorvastatin.'}, {'measure': 'Compare the efficacy of treatment with rosuvastatin with the efficacy of treatment with atorvastatin in reducing LDL-C levels'}, {'measure': 'Compare the efficacy of once daily treatment with rosuvastatin with that of atorvastatin in modifying levels of TC, HDL-C, TG, nonHDL-C (TC-HDL-C), LDL-C'}, {'measure': 'Compare the titration schedule of rosuvastatin with that of atorvastatin.'}, {'measure': 'Determine the safety by evaluating the incidence and severity of adverse events and abnormal laboratory values through 16 weeks of treatment'}]}, 'conditionsModule': {'keywords': ['Coronary Heart Disease', 'Percutaeous Coronary Intervention (PCI)'], 'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy between two lipid lowering treatments, rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein cholesterol (LDL-C) levels after 16 weeks of treatment in patients with coronary heart disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older, established coronary heart disease with a previously performed PCI, previous treatment with clopidogrel, ongoing statin treatment, LDL-C\\>2.9 mmol/L, signed informed consent.\n\nExclusion Criteria:\n\n* Ongoing treatment with clopidogrel for more than 12 weeks after randomisation, hypersensitivity to any of the study drugs, active liver disease, moderate or severe renal impairment, hereditary for or known muscular or neuromuscular disease and/or increased serum CK, pregnancy or lactation or of childbearing potential not practising an adequate method of contraception, use of concomitant medication with possible interaction with'}, 'identificationModule': {'nctId': 'NCT00235950', 'briefTitle': 'Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicentre Study Comparing the Efficacy of Rosuvastatin With Atorvastatin When Given for a Period of 16 Wks to Subjects With Coronary Heart Disease & a Previously Performed Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'D3560L00039'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rosuvastatin or atorvastatin or simvastatin and clopidogrel', 'type': 'DRUG', 'otherNames': ['Crestor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Danderyd', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.40398, 'lon': 18.02376}}, {'city': 'Eksjö', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.66643, 'lon': 14.97205}}, {'city': 'Falun', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Jönköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Karlskrona', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.16156, 'lon': 15.58661}}, {'city': 'Karlstad', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'city': 'Ljungby', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.83324, 'lon': 13.94082}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Örebro', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Skövde', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Sundsvall', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Vaxjo', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}, {'city': 'Västerås', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'AstraZeneca Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}