Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-21 @ 6:52 PM
Study NCT ID:
NCT01997294
Status:
UNKNOWN
Last Update Posted:
2016-10-11
First Post:
2013-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-09', 'studyFirstSubmitDate': '2013-11-22', 'studyFirstSubmitQcDate': '2013-11-27', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safty Endpoints', 'timeFrame': '12 months', 'description': '1. Impairment of liver and kidney function\n2. Other adverse events related to statin use'}], 'primaryOutcomes': [{'measure': 'Major Adverse Events (MACE) Occourance Rate', 'timeFrame': '30 days', 'description': '1. Cardiac Death (CD)\n2. Non-fatal re-inarction (CK-MB, cTNI or cTNT elevation again and over 3 times higher than up normal limit accompanied with syptoms or EKG indication)\n3. revascularization driven by syptoms (CABG or re-PCI)'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoints', 'timeFrame': '12 months', 'description': '1. TMP and TIMI grade chage after stents implantation; EKG ST reduction\n2. MACE ( same definition as primary endpoints)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sequential therapy', 'atorvastatin', 'acute myocardial infarction'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sighed informed consent\n* Diagnosised as acute myocardial infarction\n* Time frame less than 12 hours since the occurance of chest pain\n* Aggred to receive sirolimus-eluted coronary stents\n* Patients willing to accepte follow-up\n\nExclusion Criteria:\n\n* Allegy to statins or with a history against statin therapy\n* Allegy to any products that will be used during PPCI\n* Disagreed to receive PPCI and other related therapy\n* Existing sever liver dysfuntion that statins can not be used according to the guildlines\n* Sever kidney dysfunction (creatinine \\>3mg/dl or eGFR\\<30ml/min)\n* Sever left ventricular dysfunction (Killip grade 3)\n* Patients are currently taking medicine that may influence the use of statin\n* Patients with a history of alcohol abuse or durg abuse\n* Woman during pregnancy or lactation\n* Patients who has attended other clinical trials\n* Patients who has received PCI or CABG previously\n* Patients who can not agree to accept study protocol\n* Other conditions that may not sutible for the current study'}, 'identificationModule': {'nctId': 'NCT01997294', 'briefTitle': 'Sequential Therapy of Atorvastatin Improve Outcomes of ST-elevated Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study（The STRAIT Study）', 'orgStudyIdInfo': {'id': 'RJH20130115'}, 'secondaryIdInfos': [{'id': '2011BAI11B05', 'type': 'OTHER_GRANT', 'domain': "Ministry of Science and Techology of the Pelple's Republic of China"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sequential therapy group', 'description': '80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year', 'interventionNames': ['Drug: Sequential therapy of atorvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Therapy of atorvastatin', 'description': '20mg/d before and after PPCI for 1 year', 'interventionNames': ['Drug: Sequential therapy of atorvastatin']}], 'interventions': [{'name': 'Sequential therapy of atorvastatin', 'type': 'DRUG', 'description': '80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI', 'armGroupLabels': ['Usual Therapy of atorvastatin', 'sequential therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Dept. of Cardiology', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Weifeng Shen, MD. PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Cardiovascular Diseases, School of Medicine, Shanghai Jiao Tong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhang Qi, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Visa Chief of Department of Cardiology', 'investigatorFullName': 'Zhang Qi, MD', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}