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Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II
Sponsor: Peking University First Hospital
Summary
Individual differences in drug efficacy and adverse reactions are common in the clinical application of drugs. Individual differences are caused by many factors, among which genetic factors account for more than 20%. Novel oral anticoagulant drugs (NOACs, including rivaroxaban, apixaban, edoxaban, dabigatran, etc.) and novel antiplatelet drug ticagrelor have the advantages of convenient use and no need for monitoring. But novel oral antithrombotic drugs also increase the risk of bleeding, and there is currently a lack of effective antagonists when antithrombosis is excessive or emergency surgery is required. At present, there are few studies on the causes of individual differences in novel antithrombotic drugs, and there is a lack of predictable biomarkers or drug genotypes, especially in China. Therefore, on the basis of previous studies on NOACs and ticagrelor individualized medication cohorts, this study plans to establish a validation cohort for novel antithrombotic drugs bleeding related biomarkers, conduct multi-omics testing and long-term follow-up, and explore markers related to pharmacodynamics of antithrombotic drugs, adverse bleeding reactions and clinical outcomes.
Official title: Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II (IMPACT 2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2023-03
Completion Date
2027-12
Last Updated
2023-03-10
Healthy Volunteers
No
Conditions
Interventions
Detection of genotype and RNA profile in platelet and white blood cell
Detection of genotype by next generation sequencing Detection of RNA profile in platelet and white blood cell by RNA sequencing
Indicators test related to coagulation function
Indicators test including prothrombin time (PT), activated partial thrombin time (APTT), thrombin time (TT), diluted TT (dTT), snake vein enzyme coagulation time (ECT), anti-XA or IIa activity, etc.
Indicators test related to platelet function
Indicators test related to platelet function. Platelet reactivity was measured by VASP. Platelet aggregation rate was measured by turbidimetric method. Platelet and fibrinolytic function were measured by thrombologram, etc.
Locations (6)
Anhui Provincial Hospital#The First Affiliated Hospital Of USTC#
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital FuDan University
Shanghai, Shanghai Municipality, China