Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants
NCT ID: NCT03161496
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
1200 participants
OBSERVATIONAL
2017-06-06
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 NOACs and provide scientific basis for accurate medication guide for people to use NOACs.
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 NOACs
detection of genotype
detection of genotype by next generation sequencing
mutant genotype
Through next generation sequencing, distinguish mutant genotype of NOACs
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
* In accordance with anticoagulation indications of NOACs, include prevention of thrombosis in non valvular atrial fibrillation, prevention and treatment of deep vein thrombosis / pulmonary embolism and prevention of thrombosis after knee / hip replacement;
* More than 18 years of age, male or female;
* Never received NOACs in a month and intend to take NOACs or have received NOACs 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 CYP3A4 strong inhibitors and P-gp inhibitors (e.g., systemic pyrrole antifungal agents such as ketoconazole, itraconazole, voriconazole and posaconazole; human immunodeficiency virus (HIV) - protease inhibitors such as ritonavir), CYP3A4 strong inducers and P-gp inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort, etc.) in 14 days before treatment with NOACs;
* Severe liver dysfunction and abnormal renal function;
* Include contraindications of NOACs, 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
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 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 Hospital of Changsha
Changsha, Hunan, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Jiangnan University, or called Original Wuxi Third Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
The affiliated hospital of Inner Mongolia medical university
Hohhot, Neimenggu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhaoyi Yang, PhD
Role: primary
Qian Xiang, Ph.D
Role: primary
Yatong Zhang, MS
Role: primary
Na Wang, MS
Role: primary
Zhihong Liu
Role: primary
Dongdong Yuan, MS
Role: primary
Jianjun Sun, PhD
Role: primary
Mangmang Pan, MS
Role: primary
References
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Xiang Q, Wang Z, Mu G, Xie Q, Liu Z, Zhou S, Zhang H, Wang Z, Jiang J, Hu K, Zhang Y, Zhao Z, Yuan D, Guo L, Wu T, Zhang J, Wang N, Xiang J, Gu Z, Sun J, Cui Y. Genetic variants influenced the risk of bleeding and pharmacodynamics of rivaroxaban in patients with nonvalvular atrial fibrillation: A multicentre prospective cohort study. Clin Transl Med. 2023 May;13(5):e1263. doi: 10.1002/ctm2.1263.
Zhang H, Zhang Z, Liu Z, Mu G, Xie Q, Zhou S, Wang Z, Cao Y, Tan Y, Wei X, Yuan D, Xiang Q, Cui Y. Circulating miR-320a-3p and miR-483-5p level associated with pharmacokinetic-pharmacodynamic profiles of rivaroxaban. Hum Genomics. 2022 Dec 28;16(1):72. doi: 10.1186/s40246-022-00445-5.
Liu Z, Mu G, Xie Q, Zhang H, Jiang J, Xiang Q, Cui Y. Hemoclot Thrombin Inhibitor Assay and Expected Peak-Trough Levels of Dabigatran: A Multicenter Study. Front Cardiovasc Med. 2022 Jul 22;9:894888. doi: 10.3389/fcvm.2022.894888. eCollection 2022.
Other Identifiers
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2016[1236]
Identifier Type: -
Identifier Source: org_study_id