Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-31 @ 5:58 AM
Study NCT ID:
NCT01936103
Status:
UNKNOWN
Last Update Posted:
2013-09-05
First Post:
2013-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intensive Statin Treatment on Left Ventricular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056988', 'term': 'Anterior Wall Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-02', 'studyFirstSubmitDate': '2013-04-23', 'studyFirstSubmitQcDate': '2013-09-02', 'lastUpdatePostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'enzymes', 'timeFrame': '1 year', 'description': 'the level of CK peak'}, {'measure': 'Major adverse cardiac and cerebral events at 1 year', 'timeFrame': '1 year', 'description': '1 year after death, cardiac death , myocardial infarction , heart failure , cardiac causes hospitalization , revascularization combined endpoint of cerebrovascular events .'}, {'measure': 'Aspartate aminotransferase (AST)', 'timeFrame': '1 year', 'description': 'Aspartate aminotransferase (AST) returned to normal in the perioperative period'}, {'measure': 'enzymes', 'timeFrame': '1 year', 'description': 'CK-MB peak'}, {'measure': 'enzymes', 'timeFrame': '1 year', 'description': 'troponin (TnT)'}, {'measure': 'enzymes', 'timeFrame': '1 year', 'description': 'CK-MB peak time'}, {'measure': 'Aspartate aminotransferase (AST)', 'timeFrame': '1 year', 'description': 'any elevation\\> 3 times the proportion'}, {'measure': 'alanine aminotransferase (ALT)', 'timeFrame': '1 year', 'description': 'alanine aminotransferase (ALT)returned to normal in the perioperative period'}, {'measure': 'alanine aminotransferase (ALT)', 'timeFrame': '1 year', 'description': 'any elevation\\> 3 times the proportion'}], 'primaryOutcomes': [{'measure': 'left ventricular function', 'timeFrame': '30 days', 'description': 'ultrasonic observation of left ventricular end-diastolic diameter'}, {'measure': 'left ventricular function', 'timeFrame': '30 days', 'description': 'ultrasonic observation of left ventricular end-systolic volume'}, {'measure': 'left ventricular function', 'timeFrame': '30 days', 'description': 'ultrasonic observation of left ventricular fractional shortening RWSI'}, {'measure': 'left ventricular function', 'timeFrame': '30 days', 'description': 'ultrasonic observation of the left ventricular ejection fraction'}, {'measure': 'left ventricular function', 'timeFrame': '30 days', 'description': 'ultrasonic observation of E/A'}], 'secondaryOutcomes': [{'measure': 'the left ventricular function', 'timeFrame': '6 months'}, {'measure': 'the left ventricular function', 'timeFrame': '1 year'}, {'measure': 'plasma brain natriuretic peptide', 'timeFrame': '30days'}, {'measure': 'plasma brain natriuretic peptide', 'timeFrame': '6 months'}, {'measure': 'plasma brain natriuretic peptide', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute anterior myocardial infarction', 'Percutaneous coronary stent implantation', 'Intensive statin therapy', 'Left ventricular function'], 'conditions': ['Acute Anterior Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'First acute anterior myocardial infarction in patients with primary PCI preoperative and postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional -dose therapy , patients can improve left ventricular function , reduce major adverse cardiovascular events .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. the first time clinical diagnosis of acute anterior myocardial infarction , the time of onset ≤ 12 hours ,intends underwent emergency PCI\n3. informed consent\n\nExclusion Criteria:\n\n1. Taking , or the need for long-term use of statins is greater than the initial dose\n2. treated with PCI again within a mouth\n3. active liver disease or liver dysfunction\n4. the diagnosis of myopathy\n5. severe renal insufficiency ( serum creatinine \\> 178umol / L )\n6. Statin drug allergy or had a serious adverse reaction\n7. severe aortic stenosis or mitral stenosis , hypertrophic obstructive cardiomyopathy , pericardial disease\n8. pregnancy\n9. malignancy or any other end-stage diseases result in a life expectancy of \\< 6 months\n10. be participating in other clinical studies\n11. not suitable for inclusion of the other cases\n12. not treated with PCI'}, 'identificationModule': {'nctId': 'NCT01936103', 'briefTitle': 'Effects of Intensive Statin Treatment on Left Ventricular Function', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'officialTitle': 'Effects of Intensive Statin Therapy on Left Ventricular Function for Patients With the First Acute Anterior Myocardial Infarction After Directly to Percutaneous Coronary Intervention.', 'orgStudyIdInfo': {'id': 'NH-20120404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard group', 'description': 'patients in this group received standard statin treatment： Atorvastatin statins 20mg / night .', 'interventionNames': ['Drug: standard group']}, {'type': 'EXPERIMENTAL', 'label': 'intensive group', 'description': 'patients in this group received intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation , and thereafter 20mg / night .', 'interventionNames': ['Drug: intensive group']}], 'interventions': [{'name': 'standard group', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'standard statin treatment:Atorvastatin statins 20mg / night .', 'armGroupLabels': ['standard group']}, {'name': 'intensive group', 'type': 'DRUG', 'otherNames': ['intensive Lipitor'], 'description': 'intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation', 'armGroupLabels': ['intensive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Geng, Dr', 'role': 'CONTACT', 'phone': '13309886393'}], 'facility': 'Shenyang Northen Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Geng Wang, Dr', 'role': 'CONTACT', 'email': 'Wanggeng69@hotmail.com', 'phone': '+86-24-28897280'}], 'overallOfficials': [{'name': 'Geng Wang, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shenyang Northern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice president', 'investigatorFullName': 'Han Yaling, MD', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}