Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT03161002
Status:
UNKNOWN
Last Update Posted:
2020-12-22
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-19', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of major adverse cardiac events (MACE)', 'timeFrame': 'At 1 year', 'description': 'During the observation time, record the incidence of MACE after ticagrelor administration by telephone or outpatient clinic , including myocardial infarction, cardiac death, stent stenosis, stent thrombosis, ect.'}, {'measure': 'Incidence of bleeding events', 'timeFrame': 'At 1 year', 'description': 'During the observation time, record the incidence of bleeding events after ticagrelor administration by telephone or outpatient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.'}], 'secondaryOutcomes': [{'measure': 'genotype detected by next generation sequencing', 'timeFrame': 'pre-dose of Ticagrelor', 'description': 'Collect blood specimen before ticagrelor administration, then detect genotype of Ticagrelor by next generation sequencing.'}, {'measure': 'Level of platelet reactivity assessed by ADP aggregation rate', 'timeFrame': 'At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.', 'description': 'Before and after ticagrelor administration, record the ADP aggregation rate detected by Light Transmittance Aggregometry(LTA).'}, {'measure': 'Level of platelet reactivity assessed by PRI', 'timeFrame': 'At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.', 'description': 'Before and after ticagrelor administration, record PRI detected by VerifyNow System.'}, {'measure': 'Expression level of miRNA', 'timeFrame': 'At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.', 'description': 'Before and after ticagrelor administration, detect the expression level of miRNA about pharmacodynamics.'}, {'measure': 'Expression level of proteomics', 'timeFrame': 'At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients', 'description': 'Before and after ticagrelor administration, detect the expression level of proteomics about pharmacodynamics'}, {'measure': 'Expression level of LncRNA', 'timeFrame': 'At baseline, at 12 hours for Chinese healthy volunteers；at 48 hours for Chinese patients.', 'description': 'Before and after ticagrelor administration, detect the expression level of LncRNA about pharmacodynamics.'}, {'measure': 'Incidence of MACEs in the other observation times', 'timeFrame': 'At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens)', 'description': 'During the other observation time, record the incidence of MACE after ticagrelor administration by telephone or outpatient clinic , including myocardial infarction, cardiac death, stent stenosis, stent thrombosis, ect.'}, {'measure': 'Incidence of bleeding events in the other observation times', 'timeFrame': 'At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens)', 'description': 'During the other observation time, record the incidence of bleeding events after ticagrelor administration by telephone or outpatient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ticagrelor', 'Pharmacokinetics', 'Pharmacodynamics', 'Pharmacogenomics', 'Accurate Medication']}, 'referencesModule': {'references': [{'pmid': '35501592', 'type': 'DERIVED', 'citation': 'Xiang Q, Liu Z, Mu G, Xie Q, Zhang H, Zhou S, Wang Z, Guo N, Huang J, Jiang J, Li J, Yang G, Cui Y. Effect of Genetic Polymorphism Including NUP153 and SVEP1 on the Pharmacokinetics and Pharmacodynamics of Ticagrelor in Healthy Chinese Subjects. Clin Drug Investig. 2022 May;42(5):447-458. doi: 10.1007/s40261-022-01154-6. Epub 2022 Apr 30.'}, {'pmid': '35082514', 'type': 'DERIVED', 'citation': 'Yuan D, Shi X, Gao L, Wan G, Zhang H, Yang Y, Zhao Y, Sun D. Identification of Potential Biological Factors Affecting the Treatment of Ticagrelor After Percutaneous Coronary Intervention in the Chinese Population. Pharmgenomics Pers Med. 2022 Jan 20;15:29-43. doi: 10.2147/PGPM.S338287. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of ticagrelor in the antiplatelet efficacy and safety, through the pharmacogenomics research.\n\nThe aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug transporters and drug target genes in Chinese population. By detecting the gene polymorphism, we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG) correlation of ticagrelor and provide scientific basis for accurate medication guide for people to use ticagrelor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '(I)Chinese Healthy Volunteers：In accordance with the criteria of each bioequivalence trial of ticagrelor；150-200 cases (II)Chinese Patients：With diagnosis of acute coronary syndrome (ACS)，never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously；200 cases', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(I)Chinese Healthy Volunteers\n\n* In accordance with the inclusion criteria for each bioequivalence trial of ticagrelor;\n* Sign informed consent of the research;\n* Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug.\n\n(II)Chinese Patients\n\n* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;\n* More than 18 years of age, male or female;\n* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously；\n* sign informed consent.\n\nExclusion Criteria:\n\n(I)Chinese Healthy Volunteers\n\n* In accordance with the exclusion criteria for each bioequivalence trial of ticagrelor;\n\n(II)Chinese Patients\n\n* With history of immunodeficiency disease, including positive HIV index;\n* Positive Hepatitis B surface antigen (HBsAg) and HCV index;\n* Combined therapy of CYP3A potent inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, Atazanavir, etc.), CYP3A substrate of narrow therapy window (e.g., cyclosporine, quinidine, etc.) and potent inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine, etc.) in 14 days before treatment with ticagrelor;\n* Severe liver dysfunction and abnormal renal function;\n* Uncontrolled hypertension, or systolic blood pressure \\> 180mmHg or diastolic pressure \\> 110mmHg during screening;\n* Include contraindications of ticagrelor, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.'}, 'identificationModule': {'nctId': 'NCT03161002', 'briefTitle': 'Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor', 'orgStudyIdInfo': {'id': '2016[1235]'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'wild genotype', 'description': 'Through next generation sequencing, distinguish wild genotype of ticagrelor', 'interventionNames': ['Genetic: detection of genotype']}, {'label': 'mutant genotype', 'description': 'Through next generation sequencing, distinguish mutant genotype of ticagrelor', 'interventionNames': ['Genetic: detection of genotype']}], 'interventions': [{'name': 'detection of genotype', 'type': 'GENETIC', 'description': 'detection of genotype by next generation sequencing', 'armGroupLabels': ['mutant genotype', 'wild genotype']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaoyi Yang, PhD', 'role': 'CONTACT', 'email': 'young2382@163.com', 'phone': '+86-0551-62283379-800'}], 'facility': 'Anhui Provincial Hospital（The First Affiliated Hospital Of USTC）', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Huang, MS', 'role': 'CONTACT', 'email': 'hyayd123@126.com', 'phone': '+86-15056922343'}], 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Xiang, Ph.D', 'role': 'CONTACT', 'email': 'xiangqz@126.com', 'phone': '+86 010 66110802'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhihong Liu', 'role': 'CONTACT', 'email': 'liuzh827@sina.cn'}], 'facility': '900 Hospital of the Joint Logistics Team (Original name: Fuzhou General Hospital of Nanjing Militray Command)', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '450006', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "The 7th People's Hospital Of Zhengzhou", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The Second Affiliated Hospital Of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Qian Xiang, Ph.D', 'role': 'CONTACT', 'email': 'xiangqz@126.com', 'phone': '+86 010 66110802'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cui Yimin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of pharmacy，M.D & Ph.D', 'investigatorFullName': 'Cui Yimin', 'investigatorAffiliation': 'Peking University First Hospital'}}}}