Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor
NCT ID: NCT03161002
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2017-05-31
2021-12-31
Brief Summary
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The 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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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wild genotype
Through next generation sequencing, distinguish wild genotype of ticagrelor
detection of genotype
detection of genotype by next generation sequencing
mutant genotype
Through next generation sequencing, distinguish mutant genotype of ticagrelor
detection of genotype
detection of genotype by next generation sequencing
Interventions
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detection of genotype
detection of genotype by next generation sequencing
Eligibility Criteria
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Inclusion Criteria
* Sign informed consent of the research;
* Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug.
(II)Chinese Patients
* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;
* More than 18 years of age, male or female;
* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously；
* sign informed consent.
Exclusion Criteria
(II)Chinese Patients
* With history of immunodeficiency disease, including positive HIV index;
* Positive Hepatitis B surface antigen (HBsAg) and HCV index;
* 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;
* Severe liver dysfunction and abnormal renal function;
* Uncontrolled hypertension, or systolic blood pressure \> 180mmHg or diastolic pressure \> 110mmHg during screening;
* 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.
18 Years
ALL
Yes
Sponsors
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Cui Yimin
OTHER
Responsible Party
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Cui Yimin
Director of pharmacy，M.D & Ph.D
Locations
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Anhui Provincial Hospital（The First Affiliated Hospital Of USTC）
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
900 Hospital of the Joint Logistics Team (Original name: Fuzhou General Hospital of Nanjing Militray Command)
Fuzhou, Fujian, China
The 7th People's Hospital Of Zhengzhou
Zhengzhou, Henan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Zhaoyi Yang, PhD
Role: primary
Yan Huang, MS
Role: primary
Qian Xiang, Ph.D
Role: primary
Zhihong Liu
Role: primary
References
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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.
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.
Other Identifiers
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2016[1235]
Identifier Type: -
Identifier Source: org_study_id