Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT03526367
Status:
WITHDRAWN
Last Update Posted:
2019-09-19
First Post:
2018-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation 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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study withdrawn for no sufficient fund support.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CIAKI', 'timeFrame': '7 days', 'description': 'CIAKI, defined an Absolute Increase in SCr ≥0.5mg/dL（≥44.2μmmol/L）or a ≥ 25% Increase in SCr From Baseline to 7 days After the Procedure'}], 'secondaryOutcomes': [{'measure': 'The peak value of Scr', 'timeFrame': 'withtin 7 days before randomized'}, {'measure': 'The rate of Aggravated Heart Function', 'timeFrame': 'withtin 30 days before randomized', 'description': 'Aggravated at Least 1 Class of Heart Function'}, {'measure': 'The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration', 'timeFrame': 'withtin 30 days before randomized'}, {'measure': 'the level of hsCRP', 'timeFrame': 'withtin 7 days before randomized'}, {'measure': 'The Composite of all-cause death, MI, stroke, and TVR', 'timeFrame': 'withtin 30 days before randomized'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contrast-induced Acute Kidney Injury', 'ST Elevation Myocardial Infarction', 'Primary PCI', 'Rosuvastatin', 'Hydration']}, 'descriptionModule': {'briefSummary': "The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore. What's more, whether a synergistic effect of hydration and statin or not is unknown."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years old\n* The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);\n* The patients planned primary PCI;\n* At least one of the following:\n\nDiabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure\n\n• Voluntary signature of informed consent\n\nExclusion Criteria:\n\n* Type 2 Myocardial infarction secondary to an ischaemic imbalance\n* Intolerance of statin or iodine contrast\n* eGFR\\<30ml/min\n* Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment\n* Hepatic dysfunction, ALT 3 times greater than upper normal limit\n* Thyreoid insufficiency\n* Hemodynamic instability\n* Have received PCI or CABG within 30 day before enrollment\n* Plan to perform any coronary angiography or PCI within 30 days\n* Have received any statins within 7 days before enrollment'}, 'identificationModule': {'nctId': 'NCT03526367', 'acronym': 'TRACK-AMI', 'briefTitle': 'A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'officialTitle': 'A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of Contrast Induced Acute Kidney Injury in Patient With Acute Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention (TRACK-AMI)', 'orgStudyIdInfo': {'id': 'TRACK-AMI V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hydration plus rosuvastatin therapy', 'description': '1. After randomized，hydration（3ml/kg/h, if patients had LVEF\\<40%, 1.5 ml/kg/h）last 12 hours;\n2. After randomized，a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days.', 'interventionNames': ['Drug: hydration plus rosuvastatin therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy', 'description': "No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h.", 'interventionNames': ['Drug: Standard therapy']}], 'interventions': [{'name': 'hydration plus rosuvastatin therapy', 'type': 'DRUG', 'description': 'In experimental group,a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days and hydration（3ml/kg/h）last 12 hours after randomized', 'armGroupLabels': ['hydration plus rosuvastatin therapy']}, {'name': 'Standard therapy', 'type': 'DRUG', 'description': 'Prohibition of use any statins from randomized to 12 hours after procedure; The hydration or not is determined by physicians but 1 ml/kg/h at most.', 'armGroupLabels': ['Standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The General Hospital of Shenyang Millitary Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Yaling Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The General Hospital of Shenyang Millitary Region'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Han Yaling', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}