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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03161496
Other study ID # 2016[1236]
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 6, 2017
Est. completion date December 2021

Study information

Verified date December 2020
Source Peking University First Hospital
Contact Qian Xiang, Ph.D
Phone +86 010 66110802
Email xiangqz@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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%. Novel oral anticoagulants-NOACs (include rivaroxaban, apixaban, dabigatran and so on) have advantages of convenient use and no need of monitoring, compared with the traditional vitamin K antagonist. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of NOACs in the anticoagulant efficacy and safety, through the pharmacogenomics research. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date December 2021
Est. primary completion date October 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: (I)Chinese Healthy Volunteers - In accordance with the inclusion criteria for each bioequivalence trial of NOACs; - 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: (I)Chinese Healthy Volunteers - In accordance with the exclusion criteria for each bioequivalence trial of NOACs; (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.

Study Design


Intervention

Genetic:
detection of genotype
detection of genotype by next generation sequencing

Locations

Country Name City State
China Beijing Hospital Beijing Beijing
China Beijing HuiLongGuan Hospital Beijing Beijing
China Peking University First Hospital Beijing Beijing
China The Third Hospital of Changsha Changsha Hunan
China The Second Affiliated Hospital Of Chongqing Medical University Chongqing Chongqing
China 900 Hospital of the Joint Logistics Team (Original name: Fuzhou General Hospital of Nanjing Militray Command) Fuzhou Fujian
China Fujian Medical University Union Hospital Fuzhou Fujian
China Anhui Provincial Hospital(The First Affiliated Hospital Of USTC) Hefei Anhui
China The affiliated hospital of Inner Mongolia medical university Hohhot Neimenggu
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China The Affiliated Hospital of Qingdao University Qingdao Shandong
China Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai
China Shanghai Public Health Clinical Center Shanghai Shanghai
China the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang Liaoning
China The Affiliated Hospital of Jiangnan University, or called Original Wuxi Third Hospital Wuxi Jiangsu
China Wuxi People's Hospital Wuxi Jiangsu
China The 7th People's Hospital of Zhengzhou Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Cui Yimin

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of stroke or systemic embolic events (including TIA) During the observation time, record the incidence of stroke or systemic embolic events (including TIA) after NOACs(rivaroxaban, apixaban, dabigatran) administration by telephone or out-patient clinic. At 1 year
Primary Incidence of bleeding events During the observation time, record the incidence of bleeding events after NOACs(rivaroxaban, apixaban, dabigatran) administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. At 1 year
Secondary Genotype detected by next generation sequencing Collect blood specimen before NOACs administration, then detect genotype of NOACs by next generation sequencing. pre-dose of NOACs (rivaroxaban, apixaban, dabigatran)
Secondary Level of anticoagulant activity assessed by anti-factor Xa activity Before and after rivaroxaban and apixaban administration, record anti-factor Xa activity detected by blood coagulation tests. At baseline; at 3 hours, at 8 or 9 hours, at 12 hours for Chinese healthy volunteers, at 48 or 72 hours for Chinese patients
Secondary Level of anticoagulant activity assessed by anti-factor IIa activity Before and after dabigatran administration, record anti-factor IIa activity detected by blood coagulation tests. At baseline; at 2 hours, at 4 hours, at 8 hours, at 12 hours for Chinese healthy volunteers, at 72 hours for Chinese patients
Secondary Expression level of miRNA Before and after NOACs administration, detect the expression level of miRNA about pharmacodynamics. At baseline; at 2 or 3 hours, at 4 hours (only for dabigatran), at 8 or 9 hours, at 12 hours for Chinese healthy volunteers, at 48 or 72 hours for Chinese patients.
Secondary Expression level of LncRNA Before and after NOACs administration, detect the expression level of LncRNA about pharmacodynamics. At baseline; at 2 or 3 hours, at 4 hours (only for dabigatran), at 8 or 9 hours, at 12 hours for Chinese healthy volunteers, at 48 or 72 hours for Chinese patients.
Secondary Incidence of stroke or systemic embolic events in the other observation times During the other observation time, record the incidence of stroke or systemic embolic events (including TIA) after NOACs(rivaroxaban, apixaban, dabigatran) administration by telephone or out-patient clinic. At 1 month, 6 months and 2 years (according the actual duration of NOACs taken in patiens)
Secondary Incidence of bleeding events in the other observation times During the other observation time, record the incidence of bleeding events after NOACs(rivaroxaban, apixaban, dabigatran) administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. At 1 month, 6 months and 2 years (according the actual duration of NOACs taken in patiens)
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