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

Peking University

Status

Not yet enrolling

Conditions

Dabigatran

NOACs

Apixaban

Pharmacogenomics

Edoxaban

Novel Oral Anticoagulants

Pharmacodynamics

Ticagrelor

Biomarker

Rivaroxaban

RNA Profile

Bleeding

Treatments

Other: Indicators test related to coagulation function

Other: Indicators test related to platelet function

Genetic: Detection of genotype and RNA profile in platelet and white blood cell

Study type

Observational

Funder types

Other

Identifiers

NCT05764356

2022CR67

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(I) Chinese Patients taking NOACs

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.

(II) Chinese Patients taking ticagrelor

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

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 antithrombosis, 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.