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NOT YET RECRUITING
NCT05764356

Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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

Interventions

GENETIC

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

OTHER

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.

OTHER

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