Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-04-11 @ 3:51 PM
Study NCT ID:
NCT02070159
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2014-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prasugrel With Lower Dose - Loading Dose
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'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}], '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'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-21', 'studyFirstSubmitDate': '2014-02-08', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet reactivity', 'timeFrame': 'at 6 hours after administration of study drug. (2 hours for prasugrel groups)', 'description': 'Platelet reactivity was measured using traditional light transmission aggregometry (LTA), VerifyNow (Accumetrics, San Diego, CA, USA), and multiple electrode aggregometry (MEA, Dynabyte Medical, Munich, Germany).\n\nThe platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).'}], 'secondaryOutcomes': [{'measure': 'Percent inhibition', 'timeFrame': 'at 6 hours after administration of study drug. (2 hours for prasugrel groups)', 'description': 'Percent inhibition is calculated using the following fomula: % inhibition = \\[(baseline reactivity unit - peak reactivity unit) / baseline reactivity unit\\] × 100.\n\nPercent inhibition is measured at the time of peak platelet inhibition. The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).'}, {'measure': 'HPR', 'timeFrame': 'at 6 hours after administration of study drug. (2 hours for prasugrel groups)', 'description': 'The high platelet reactivity (HPR) was defined as the results of LTA ≥ 48% or ≥ 55%, PRU ≥ 242 or ≥ 275, and result of MEA assay ≥ 37 U or 54 U at the time of peak platelet inhibition The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).'}, {'measure': 'LPR', 'timeFrame': 'at 6 hours after administration of study drug. (2 hours for prasugrel groups)', 'description': 'The low platelet reactivity (LPR) was defined as LTA \\< 12, PRU \\< 85, MEA \\< 19 at the time of peak platelet inhibition.\n\nThe platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).'}, {'measure': 'Bleeding event', 'timeFrame': '30 days after study drug administration', 'description': 'Any event related to bleeding including access site bleeding and peri-procedural bleeding based on BARC and ACUITY criteria.'}, {'measure': 'Adverse reaction', 'timeFrame': '30 days after study drug administration', 'description': 'Any adverse reaction related to study drug.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'prasugrel', 'platelet function tests'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '23363643', 'type': 'BACKGROUND', 'citation': 'Kim MH, Zhang HZ, Jung DK. Pharmacodynamic comparisons for single loading doses of prasugrel (30 mg) and clopidogrel (600 mg) in healthy Korean volunteers. Circ J. 2013;77(5):1253-9. doi: 10.1253/circj.cj-12-0783. Epub 2013 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. The investigators compared the effect of lower loading dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.', 'detailedDescription': 'Although clopidogrel together aspirin has been a backbone of anti-platelet therapy in coronary artery disease patients, clopidogrel has several limitations. It has delayed onset of peak concentration and pharmacodynamic inter-patient response variability resulting in high on-treatment platelet reactivity (HPR). Those demerits are known to be associated with adverse cardiovascular outcomes.\n\nPrasugrel has a more effective metabolism pathway than clopidogrel and exhibits more rapid and potent platelet inhibition. Recent guidelines recommend prasugrel as a first line antiplatelet agent or put precedence over clopidogrel for the patients with acute coronary syndrome. However, there have been concerns of different pharmacodynamic and pharmacokinetic response to prasugrel in East Asian ethnicities.\n\nIn addition, lower loading dose of prasugrel exhibited more potent pharmacodynamic effect than clopidogrel 600 mg with comparable efficacy compared to conventional loading dose of prasugrel in healthy Korean subjects.\n\nThe investigators compare the antiplatelet effect of lower loading dose of prasugrel 30 mg with conventional loading dose of clopidogrel 600 mg and prasugrel 60 mg in Korean coronary artery disease patients undergoing elective coronary angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 80 years\n* Stable or unstable angina\n* Planned to undergo elective coronary angiography\n\nExclusion Criteria:\n\n* Previous history of transient ischemic attack or stroke\n* Intracranial neoplasm\n* Uncontrolled malignant disease\n* History of antiplatelet or anticoagulation treatment within 1 month\n* Contraindication to the study drug\n* Bleeding diathesis\n* Hemoglobin \\< 10 g/dl\n* Platelet count \\< 100,000/mm3\n* Significant renal insufficiency (glomerular filtration rate \\<60 mL/min/1.73 m2)\n* Significant hepatic impairment (Serum liver enzyme or bilirubin \\> 3 times normal limit)\n* Body weight \\< 50 kg'}, 'identificationModule': {'nctId': 'NCT02070159', 'acronym': 'PRELOAD-LD', 'briefTitle': 'Prasugrel With Lower Dose - Loading Dose', 'organization': {'class': 'OTHER', 'fullName': 'Dong-A University'}, 'officialTitle': 'Effect of Lower Loading Dose of Prasugrel Compared With Conventional Loading Dose of Clopidogrel and Prasugrel in Korean Coronary Artery Disease Patients Undergoing Coronary Angiography', 'orgStudyIdInfo': {'id': 'PRELOAD-LD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel 600 mg', 'description': 'Patients administer conventional loading dose of clopidogrel 600 mg as active comparators.', 'interventionNames': ['Drug: Clopidogrel 600 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Prasugrel 30 mg', 'description': 'Patients administer lower loading dose of prasugrel 30 mg.', 'interventionNames': ['Drug: Prasugrel 30 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prasugrel 60 mg', 'description': 'Patients administer conventional loading dose of prasugrel 60 mg as active comparators.', 'interventionNames': ['Drug: Prasugrel 60 mg']}], 'interventions': [{'name': 'Clopidogrel 600 mg', 'type': 'DRUG', 'otherNames': ['Plavix 600 mg'], 'description': 'Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel', 'armGroupLabels': ['Clopidogrel 600 mg']}, {'name': 'Prasugrel 30 mg', 'type': 'DRUG', 'otherNames': ['Effient 30 mg'], 'description': 'Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.', 'armGroupLabels': ['Prasugrel 30 mg']}, {'name': 'Prasugrel 60 mg', 'type': 'DRUG', 'otherNames': ['Effient 60 mg'], 'description': 'Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.', 'armGroupLabels': ['Prasugrel 60 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-715', 'city': 'Busan', 'country': 'South Korea', 'facility': 'DongA University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital', 'investigatorFullName': 'Moo Hyun Kim', 'investigatorAffiliation': 'Dong-A University'}}}}