Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT01498003
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2011-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tirofiban in Stenting for Long Coronary Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'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': 'D000077330', 'term': 'Saline Solution'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 748}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-13', 'studyFirstSubmitDate': '2011-12-11', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'periprocedural infarction', 'timeFrame': '12h after procedure', 'description': 'definition of periprocedural MI is a CK elevation \\>3 times the upper limit of normal.'}], 'secondaryOutcomes': [{'measure': 'major bleeding', 'timeFrame': 'during hospitalization (up to 2 weeks)', 'description': 'The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition'}, {'measure': 'major adverse cardiac event', 'timeFrame': 'one year after procedure', 'description': 'major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary disease', 'stents', 'thrombosis', 'myocardial infarction', 'prognosis'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25630513', 'type': 'DERIVED', 'citation': 'Zhang Q, Wang XL, Liao ML, Hu J, Yang ZK, Ding FH, Zhang JS, Du R, Zhu TQ, Shen WF, Zhang RY. Periprocedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions in stable patients with overlapping drug-eluting stents--the PETITION study: a prospective, randomized, multicenter study. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:762-9. doi: 10.1002/ccd.25864.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25630513', 'label': 'published results'}]}, 'descriptionModule': {'briefSummary': 'Periprocedural myonecrosis or infarction are associated with short, intermediate, and long term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence of periprocedural infarciton in elective patients with long coronary lesions treated by overlapping use of drug-eluting stents.', 'detailedDescription': 'According to the results of 12.6% occurrence of peri-procedural myocardial infarction after long stent implantation by previous report\\[International Journal of Cardiology 2009;134: 231-237\\], the investigator hypothesize the 50% reduction of peri-procedural MI by using tirofiban. Three hundred and sixty-nine patients in each group are needed to reach 80% of power with α 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18y\\~80y, with symptomatic coronary disease\n* At least one lesion length more than 40mm to be treated by overlapping drug-eluting stents in major epicardial coronary vessel\n\nExclusion Criteria:\n\n* Aspirin or clopidogrel intolerance\n* Lesions length less than 40mm, or overlapping stent length less than 40mm\n* Bifurcation lesions need to be treated by two stents\n* Patients with acute coronary syndrome and elevated baseline cardiac enzyme (CK-MB)\n* Left ventricular ejection fraction less than 0.35\n* Baseline estimated GFR less than 30\n* Estimated life time less than one year\n* Refuse to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT01498003', 'acronym': 'PETITION', 'briefTitle': 'Tirofiban in Stenting for Long Coronary Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent', 'orgStudyIdInfo': {'id': '20111211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'normal saline was applied to those randomized to control group, with same use as tirofiban', 'interventionNames': ['Drug: normal saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'Tirofiban group', 'description': 'after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion', 'interventionNames': ['Drug: tirofiban']}], 'interventions': [{'name': 'tirofiban', 'type': 'DRUG', 'otherNames': ['Xinweining, Grand Pharmaceutical Group, Wuhan, China'], 'description': '10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h', 'armGroupLabels': ['Tirofiban group']}, {'name': 'normal saline solution', 'type': 'DRUG', 'description': 'same use as tirofiban', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'WeiFeng Shen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director of Cath. Lab', 'investigatorFullName': 'Zhang Qi, MD', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}