Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT01032668
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance
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': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-14', 'studyFirstSubmitDate': '2009-12-14', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths', 'timeFrame': '6 months.'}], 'secondaryOutcomes': [{'measure': 'Major or minor bleeding according to TIMI criteria 30 days and 6 months To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit 30 days and 6 months.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['percutaneous coronary intervention, clopidogrel resistance, ASA resistance'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '19463377', 'type': 'BACKGROUND', 'citation': 'Aleil B, Jacquemin L, De Poli F, Zaehringer M, Collet JP, Montalescot G, Cazenave JP, Dickele MC, Monassier JP, Gachet C. Clopidogrel 150 mg/day to overcome low responsiveness in patients undergoing elective percutaneous coronary intervention: results from the VASP-02 (Vasodilator-Stimulated Phosphoprotein-02) randomized study. JACC Cardiovasc Interv. 2008 Dec;1(6):631-8. doi: 10.1016/j.jcin.2008.09.004.'}, {'pmid': '21239075', 'type': 'DERIVED', 'citation': 'Ari H, Ozkan H, Karacinar A, Ari S, Koca V, Bozat T. The EFFect of hIgh-dose ClopIdogrel treatmENT in patients with clopidogrel resistance (the EFFICIENT trial). Int J Cardiol. 2012 Jun 14;157(3):374-80. doi: 10.1016/j.ijcard.2010.12.083. Epub 2011 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance', 'detailedDescription': 'Aim:\n\nPrimary objective:\n\n* To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI in patients with clopidogrel resistance\n\nSecondary objective:\n\n* To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI\n* To evaluate the effect of continuing high dose clopidogrel treatment on bleeding complications after elective PCI\n* To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit.\n\nStudy central:\n\nBursa Postgraduate Hospital, Cardiology Clinic\n\nStudy population:\n\nwe planned to enrol 180 patients. 50% of patients without clopidogrel resistance (control group: 90 patients) 50% have clopidogrel resistance. Than we randomise the patients (with clopidogrel resistance) in two groups (group 1:45 patients (75mg/day), group 2:45 patients (150mg/day))\n\ninclusion criteria:\n\n* The patients; who have planned elective PCI and have had written informed consent for participation to study.\n* Age\\>18 year-old,\n* The native coronary artery;lesion with narrowing \\>=70%\n\nExclusion criteria:\n\n* Patients have allergy for ASA, Clopidogrel and heparin\n* Patients who performed primary PCI\n* Patients with acute coronary syndrome\n* Patients with have a history of PCI and use clopidogrel\n* Patients on warfarin therapy\n* Patients who have bleeding diathesis, or have high risk for bleeding.\n\nStudy works:\n\n* Write case report form for all patients\n* Control for inclusion criteria.\n* Evaluate the clopidogrel and ASA resistance with VerifyNow kit. Than randomised the patients.\n* Demographic data (age, gender)\n* Height, weight, BMI and GFR\n* Risk factors\n* laboratory data (biochemical and hematologic)\n* Medication history\n* Echocardiographic data\n* Angiographic data\n* PCI data(vessel diameter, stent diameter, lesion and stent length, performed PTCA or not, etc)\n* Note complication (MACE, bleeding, hematoma etc)\n\n 4 weeks later note the first control data and re assess the clopidogrel resistance with VerifyNow kit in patients groups 1 and 2.\n\nSix months later note the second control data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients; who have planned elective PCI and have had written informed consent for participation to study.\n* Age\\>18 year-old,\n* The native coronary artery;lesion with narrowing \\>=70%\n\nExclusion Criteria:\n\n* Patients have allergy for ASA, Clopidogrel and heparin\n* Patients who performed primary PCI\n* Patients with acute coronary syndrome\n* Patients with have a history of PCI and use clopidogrel\n* Patients on warfarin therapy\n* Patients who have bleeding diathesis, or have high risk for bleeding.'}, 'identificationModule': {'nctId': 'NCT01032668', 'acronym': 'EFFICIENT', 'briefTitle': 'The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Bursa Postgraduate Hospital'}, 'orgStudyIdInfo': {'id': 'BYİEAH2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high dose clopidogrel', 'interventionNames': ['Drug: Clopidogrel']}], 'interventions': [{'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'high dose clopidogrel continuing after percutaneous coronary intervention', 'armGroupLabels': ['high dose clopidogrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16320', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Hasan ARI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Postgraduate Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Postgraduate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi', 'oldOrganization': 'Cardiology'}}}}