Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-28 @ 2:28 PM
Study NCT ID:
NCT02592720
Status:
UNKNOWN
Last Update Posted:
2015-10-30
First Post:
2015-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cocktail Injection Improves Outcomes of FFR Guided PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '1 year', 'description': 'number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization'}], 'secondaryOutcomes': [{'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': {'keywords': ['Acute Coronary Syndromes', 'Fractional Flow Reserve', 'Percutaneous Coronary Intervention'], 'conditions': ['Acute Coronary Syndromes']}, 'descriptionModule': {'briefSummary': 'This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).', 'detailedDescription': 'This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include 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* patients with a clinical diagnosis of recent ACS within 5 days\n\nExclusion Criteria:\n\n* haemodynamic instability\n* intolerance to anti-platelet drugs\n* ineligible for coronary revascularization\n* a treatment plan for non-coronary heart surgery (e.g. valve surgery)\n* a history of prior PCI or CABG\n* angiographic evidence of severe (e.g. diffuse calcification) or mild (\\<30% severity) coronary disease\n* a life expectancy less than 1 year\n* adenosine allergy'}, 'identificationModule': {'nctId': 'NCT02592720', 'acronym': 'CocktailII', 'briefTitle': 'Cocktail Injection Improves Outcomes of FFR Guided PCI', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)', 'orgStudyIdInfo': {'id': 'Cocktail II-FFR ACS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cocktail plus FFR guided group', 'description': 'Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).', 'interventionNames': ['Drug: cocktail', 'Device: FFR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'QCA guided group', 'description': 'Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).', 'interventionNames': ['Device: QCA guided group']}], 'interventions': [{'name': 'cocktail', 'type': 'DRUG', 'otherNames': ['cocktail (tirofiban, bivalirudin, tenecteplase)'], 'description': 'Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).', 'armGroupLabels': ['Cocktail plus FFR guided group']}, {'name': 'FFR', 'type': 'DEVICE', 'otherNames': ['pressure wire (St. Jude Medical, Inc.)'], 'description': 'Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).', 'armGroupLabels': ['Cocktail plus FFR guided group']}, {'name': 'QCA guided group', 'type': 'DEVICE', 'description': 'Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).', 'armGroupLabels': ['QCA guided group']}]}, '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': 'Wanrong Man, MD', 'role': 'CONTACT', 'email': 'manwanrong@gmail.com', 'phone': '86 29 84775183'}, {'name': 'Dongdong Sun, MD,Phd', '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'}}}}