Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-28 @ 6:30 PM
Study NCT ID:
NCT01058057
Status:
UNKNOWN
Last Update Posted:
2010-02-03
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2010-01-27', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'periprocedural myocardial infarction measured by troponin I level', 'timeFrame': '24 hours after PCI'}], 'secondaryOutcomes': [{'measure': 'periprocedural myocardial infarction measured by creatinine kinase myocardial band', 'timeFrame': '24 hours after PCI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atorvastatin', 'percutaneous coronary intervention', 'periprocedural myocardial infarction', 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'], 'conditions': ['Coronary Artery Disease', 'Coronary Angioplasty']}, 'referencesModule': {'references': [{'pmid': '19699335', 'type': 'BACKGROUND', 'citation': 'Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tesar D. Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24.'}, {'pmid': '19643320', 'type': 'BACKGROUND', 'citation': 'Di Sciascio G, Patti G, Pasceri V, Gaspardone A, Colonna G, Montinaro A. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol. 2009 Aug 4;54(6):558-65. doi: 10.1016/j.jacc.2009.05.028. Epub 2009 Jul 2.'}, {'pmid': '17826370', 'type': 'BACKGROUND', 'citation': 'Mood GR, Bavry AA, Roukoz H, Bhatt DL. Meta-analysis of the role of statin therapy in reducing myocardial infarction following elective percutaneous coronary intervention. Am J Cardiol. 2007 Sep 15;100(6):919-23. doi: 10.1016/j.amjcard.2007.04.022. Epub 2007 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.', 'detailedDescription': 'This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.\n\nTwo arms:\n\n1. atorvastatin pre-treatment group (80mg atorvastatin for seven days)\n2. control group (without atorvastatin pre-treatment, chronic statin treatment)\n\nPrimary endpoint:\n\nPeriprocedural myocardial infarction measured by troponin I level (time frame 24 hours)\n\nSecondary endpoint:\n\nPeriprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for percutaneous coronary intervention\n* Informed consent\n* Chronic statin therapy\n\nExclusion Criteria:\n\n* Acute coronary syndrome in last 14 days\n* Renal insufficiency (creatinine more 150 umol/l)\n* Diseases severely limiting prognosis\n* Previous participation in this study\n* Chronic occlusion of the coronary artery, bypass intervention, left main intervention\n* Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin'}, 'identificationModule': {'nctId': 'NCT01058057', 'acronym': 'TIPS-2', 'briefTitle': 'Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Motol'}, 'officialTitle': 'Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2', 'orgStudyIdInfo': {'id': 'KC EK-150/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atorvastatin', 'description': 'Atorvastatin 80mg seven days pre-treatment before PCI', 'interventionNames': ['Drug: atorvastatin']}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Torvacard'], 'description': 'atorvastatin 80mg p.o. daily seven days before PCI', 'armGroupLabels': ['Atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15018', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'David Zemanek, MD', 'role': 'CONTACT', 'email': 'zejada@seznam.cz', 'phone': '+420608921566'}], 'facility': 'Dpt. of Cardiology, University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'David Zemanek, MD', 'role': 'CONTACT', 'email': 'zejada@seznam.cz', 'phone': '+420608921'}], 'overallOfficials': [{'name': 'David Zemanek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, University Hospital Motol'}, {'name': 'Josef Veselka, Prof., MD., PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Carldiology, University Hospital Motol'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Motol', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Anna Sediva, MD, PhD', 'oldOrganization': 'University Hospital Motol'}}}}