Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT02487732
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2015-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting
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': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2015-06-27', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in circulating number of endothelial progenitor cells', 'timeFrame': 'Expected average of 5 weeks'}, {'measure': 'Changes in brachial artery flow mediated dilation', 'timeFrame': 'Expected average of 5 weeks'}], 'secondaryOutcomes': [{'measure': 'Composite measure of brachial-ankle pulse wave velocity, and augmentation index.', 'timeFrame': 'Expected average of 5 weeks'}]}, 'conditionsModule': {'keywords': ['Diabetic Patients With Non-ST Elevation'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '28838475', 'type': 'DERIVED', 'citation': 'Jeong HS, Hong SJ, Cho SA, Kim JH, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW, Lim DS. Comparison of Ticagrelor Versus Prasugrel for Inflammation, Vascular Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST-Segment Elevation Acute Coronary Syndrome Requiring Coronary Stenting: A Prospective, Randomized, Crossover Trial. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1646-1658. doi: 10.1016/j.jcin.2017.05.064.'}]}, 'descriptionModule': {'briefSummary': 'To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70\n3. Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)\n\nExclusion Criteria:\n\n1. Hypersensitivity to ticagrelor, prasugrel or any of the excipients\n2. No prior use of either ticagrelor or prasugrel within a month prior to randomization.\n3. History of intracranial bleeding at any time\n4. Active pathologic bleeding\n5. Hemoglobin A1c \\>9%\n6. Type 1 diabetes\n7. Decreased serum platelet level (\\< 100,000/uL)\n8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin\n9. Gastrointestinal bleed within the past 6 months, or major surgery within 30 days\n10. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study\n11. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study\n12. Involvement in the planning and/or conduct of the study\n13. Left ventricular ejection fraction \\< 40%\n14. Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \\> twice the upper limit)\n15. Gastrointestinal disorder such as Crohn's disease\n16. Alcohol abuse\n17. Steroid or hormone replacement therapy\n18. Serum creatinine \\> 2.0 mg/dL.\n19. Prior history of CVA or stroke\n20. Body weight \\< 60 kg\n21. Life expectancy less than a year\n22. Known pregnancy, breast-feeding, or intend to become pregnant during the study period"}, 'identificationModule': {'nctId': 'NCT02487732', 'briefTitle': 'Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'orgStudyIdInfo': {'id': 'Adenosine diphosphate blockers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ticagrelor', 'description': '180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel', 'interventionNames': ['Drug: Ticagrelor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prasugrel', 'description': '60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor', 'interventionNames': ['Drug: Prasugrel']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brilinta'], 'description': 'Ticagrelor 90mg twice daily for 5 weeks', 'armGroupLabels': ['Ticagrelor']}, {'name': 'Prasugrel', 'type': 'DRUG', 'otherNames': ['Effient'], 'description': 'Prasugrel 10mg once daily for 5 weeks', 'armGroupLabels': ['Prasugrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Soon Jun Hong', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}