Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT02592694
Status:
UNKNOWN
Last Update Posted:
2015-10-30
First Post:
2015-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty
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': 'D000077466', 'term': 'Tirofiban'}, {'id': 'C074619', 'term': 'bivalirudin'}, {'id': 'D000077785', 'term': 'Tenecteplase'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2015-10-28', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death, Mayocardial infarction, NYHA Ⅳ heart failure', 'timeFrame': '1 year', 'description': 'number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure'}], 'secondaryOutcomes': [{'measure': 'Slow reflow/no reflow', 'timeFrame': 'intraoperative', 'description': 'number of participants with slow reflow/no reflow during PCI'}, {'measure': 'Left ventricular function', 'timeFrame': '1 year', 'description': 'left ventricular ejection fraction evaluated by ultrasound and MRI'}, {'measure': 'Seattle Angina Questionnaire scores', 'timeFrame': '1 year', 'description': 'Seattle Angina Questionnaire scores'}, {'measure': 'Canadian Cardiovascular Society (CCS) Functional Angina classification', 'timeFrame': '1 year', 'description': 'Canadian Cardiovascular Society (CCS) Functional Angina classification'}, {'measure': '6-minute walk distance (6MWD)', 'timeFrame': '1 year', 'description': '6-minute walk distance (6MWD)'}, {'measure': 'Stroke', 'timeFrame': '1 year', 'description': 'number of participants with stroke'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ST-elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.', 'detailedDescription': 'This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty. Patients with STEMI will be randomized into the cocktail group or the control group. Patients in the cocktail group will receive cocktail injection combined with thrombus aspiration. Patients in the control group will receive thrombus aspiration alone. The primary outcome of the cocktail I study is the composite of death, myocardial infarction or class IV heart failure within 1 year. The secondary outcome of the cocktail I study include slow reflow/no reflow during PCI, left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset\n\nExclusion Criteria:\n\n* Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT'}, 'identificationModule': {'nctId': 'NCT02592694', 'briefTitle': 'Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty', 'orgStudyIdInfo': {'id': 'Cocktail I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cocktail with thrombus aspiration', 'description': 'Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration', 'interventionNames': ['Drug: cocktail', 'Device: thrombus aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thrombus aspiration', 'description': 'Thrombus aspiration alone', 'interventionNames': ['Device: thrombus aspiration']}], 'interventions': [{'name': 'cocktail', 'type': 'DRUG', 'otherNames': ['tirofiban, bivalirudin, tenecteplase'], 'description': 'Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration', 'armGroupLabels': ['Cocktail with thrombus aspiration']}, {'name': 'thrombus aspiration', 'type': 'DEVICE', 'otherNames': ['manual thrombus aspiration'], 'description': 'manual thrombus aspiration', 'armGroupLabels': ['Cocktail with thrombus aspiration', 'Thrombus aspiration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongdong Sun, M.D.,Ph.D', 'role': 'CONTACT', 'email': 'wintersun3@gmail.com', 'phone': '86 18691569930'}], 'facility': 'Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Dongdong Sun, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'wintersun3@gmail.com', 'phone': '86 29 84775183'}], 'overallOfficials': [{'name': 'Dongdong Sun, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'sunddong', 'investigatorAffiliation': 'Xijing Hospital'}}}}