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

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Mar 1, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Impact of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II" aims to understand how individual differences in genetics and other factors affect the effectiveness and safety of certain blood-thinning medications. These medications, known as novel oral anticoagulants (NOACs) like rivaroxaban and apixaban, and the antiplatelet drug ticagrelor, are commonly used to prevent blood clots. While they are convenient and do not require regular monitoring, they can increase the risk of bleeding. This study seeks to identify specific genetic markers that could help predict how patients respond to these drugs, which could lead to safer and more personalized treatment options.

To participate in this study, individuals must be Chinese patients who are either taking NOACs for conditions like atrial fibrillation or have a diagnosis of acute coronary syndrome and are taking ticagrelor. Participants need to be over 18 years old and must not have taken these medications in the month prior to joining the study. Throughout the trial, participants will undergo various tests and have regular follow-ups to monitor their health and any potential side effects. This research is important as it aims to fill a gap in understanding how these medications work in different individuals, ultimately improving treatment for patients in the future.

Gender

ALL

Eligibility criteria

• 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.