Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01371058
Status:
COMPLETED
Last Update Posted:
2015-12-16
First Post:
2011-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080710', 'term': 'policosanol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-15', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reversion rate of HPR', 'timeFrame': '30 days', 'description': 'reversion was defined as platelet aggregation \\<65%'}], 'secondaryOutcomes': [{'measure': 'major adverse cardiovascular events', 'timeFrame': '1 year', 'description': 'including cardiac death, non-fatal myocardial infarction and target vessel revascularization'}, {'measure': 'Stent thrombosis and TIMI bleeding events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['high on-treatment platelet reactivity', 'percutaneous coronary intervention', 'stent thrombosis'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice\n\nThe aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .', 'detailedDescription': 'Thrombotic event is one of the most serious complications in coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary heart disease and had received coronary stenting\n* high on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by LTA)\\> 65% at 24 hr after clopidogrel loading (300 \\~ 600mg)or 5 days after maintenance dose treatment (75mg / d)\n* Informed Consent\n\nExclusion Criteria:\n\n* receiving GP IIb / IIIa receptor antagonist treatment within 24h before enrollment\n* using cilostazol within 7d before enrollment\n* aspirin, clopidogrel or policosanol allergies\n* NYHA grade III \\~ IV\n* planned elective coronary revascularization for multivessel coronary artery disease\n* long term warfarin treatment after persistent atrial fibrillation, valve surgery or other circumstance\n* Severe liver or kidney dysfunction\n* Active ulcer or a history of recent gastrointestinal bleeding\n* History of coagulation disorder, or recent history of active bleeding\n* history of intracranial hemorrhage within 6 months\n* Pregnancy\n* LDL less than 70mg/dL\n* Severe systemic diseases with life expectancy less than 1 year\n* planned surgery within next 6 months'}, 'identificationModule': {'nctId': 'NCT01371058', 'acronym': 'spirit', 'briefTitle': 'Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'officialTitle': 'Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)', 'orgStudyIdInfo': {'id': 'NH-20110530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'routine dual antiplatelet', 'description': 'asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year.', 'interventionNames': ['Drug: routine dual antiplatelet']}, {'type': 'EXPERIMENTAL', 'label': 'high maintenance clopidogrel', 'description': 'aspirin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 150mg/d for 1 month followed by 75mg/d for at least 1 year.', 'interventionNames': ['Drug: high maintenance clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'policosanol plus dual antiplatelet', 'description': 'asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.', 'interventionNames': ['Drug: policosanol plus dual antiplatelet']}], 'interventions': [{'name': 'high maintenance clopidogrel', 'type': 'DRUG', 'description': 'clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；', 'armGroupLabels': ['high maintenance clopidogrel']}, {'name': 'routine dual antiplatelet', 'type': 'DRUG', 'description': 'clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；', 'armGroupLabels': ['routine dual antiplatelet']}, {'name': 'policosanol plus dual antiplatelet', 'type': 'DRUG', 'description': 'aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months', 'armGroupLabels': ['policosanol plus dual antiplatelet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Yaling Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenyang Northern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Han Yaling', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}