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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel oral anticoagulants cohort |
| ||
| Ticagrelor cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detection of genotype and RNA profile in platelet and white blood cell | Genetic | Detection of genotype by next generation sequencing Detection of RNA profile in platelet and white blood cell by RNA sequencing |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new bleeding events | During the observation time, record the incidence of new bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. | Within 1 month after enrollment |
| Incidence of new bleeding events | During the observation time, record the incidence of new 'bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. | From 1 month to 6 months after enrollment |
| Incidence of new bleeding events | During the observation time, record the incidence of new bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. | From 6 months to 1 year after enrollment |
| Incidence of new bleeding events | During the observation time, record the incidence of new bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc. | From 1 year to 2 years after enrollment |
| Incidence of new major cardiovascular events and all-cause death | During the observation time, record the new incidence of major cardiovascular events (MACEs) and all-cause death after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic. MACEs including cardiac death, myocardial infarction (MI), stroke or transient cerebral thrombus (TIA), ischemic-driven coronary revascularization(PCI, CABG, thrombolysis, etc.), etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Genotype detected by next generation sequencing | Collect blood specimen before NOACs administration, then detect genotype of NOACs by next generation sequencing. | Through study completion, collection only once |
| Expression level of RNA in platelet and white blood cell |
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Inclusion Criteria:
(I) Chinese Patients taking NOACs
(II) Chinese Patients taking ticagrelor
Exclusion Criteria:
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Chinese Patients taking NOACs or ticagrelor#In accordance with anticoagulation indications of NOACs or with diagnosis of acute coronary syndrome (ACS)# received NOACs or ticagrelor in a month and intend to take NOACs or ticagrelor, or have received NOACs or ticagrelor for more than one week continuously#1000 patients for each cohort (NOACs or ticagrelor).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Xiang, Dr. | Contact | +86-18610260623 | xiangqz@pkufh.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital#The First Affiliated Hospital Of USTC# | Hefei | Anhui | China |
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| Indicators test related to coagulation function | Other | 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 | Other | 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. |
|
| Within 1 month after enrollment |
| Incidence of new major cardiovascular events and all-cause death | During the observation time, record the new incidence of major cardiovascular events (MACEs) and all-cause death after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic. MACEs including cardiac death, myocardial infarction (MI), stroke or transient cerebral thrombus (TIA), ischemic-driven coronary revascularization(PCI, CABG, thrombolysis, etc.), etc. | From 1 month to 6 months after enrollment |
| Incidence of new major cardiovascular events and all-cause death | During the observation time, record the new incidence of major cardiovascular events (MACEs) and all-cause death after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic. MACEs including cardiac death, myocardial infarction (MI), stroke or transient cerebral thrombus (TIA), ischemic-driven coronary revascularization(PCI, CABG, thrombolysis, etc.), etc. | From 6 months to 1 year after enrollment |
| Incidence of new major cardiovascular events and all-cause death | During the observation time, record the new incidence of major cardiovascular events (MACEs) and all-cause death after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic. MACEs including cardiac death, myocardial infarction (MI), stroke or transient cerebral thrombus (TIA), ischemic-driven coronary revascularization(PCI, CABG, thrombolysis, etc.), etc. | From 1 year to 2 years after enrollment |
| Incidence of new thromboembolic events | During the observation time, record the incidence of new thromboembolic events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including stroke or TIA, systemic embolism (SE), deep vein thrombosis (DVT), pulmonary embolism, left auricular thrombus, stent thrombosis, stent stenosis and stent endothelial hyperplasiastent, etc. | Within 1 month after enrollment |
| Incidence of new thromboembolic events | During the observation time, record the incidence of new thromboembolic events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including stroke or TIA, systemic embolism (SE), deep vein thrombosis (DVT), pulmonary embolism, left auricular thrombus, stent thrombosis, stent stenosis and stent endothelial hyperplasiastent, etc. | From 1 month to 6 months after enrollment |
| Incidence of new thromboembolic events | During the observation time, record the incidence of new thromboembolic events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including stroke or TIA, systemic embolism (SE), deep vein thrombosis (DVT), pulmonary embolism, left auricular thrombus, stent thrombosis, stent stenosis and stent endothelial hyperplasiastent, etc. | From 6 months to 1 year after enrollment |
| Incidence of new thromboembolic events | During the observation time, record the incidence of new thromboembolic events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including stroke or TIA, systemic embolism (SE), deep vein thrombosis (DVT), pulmonary embolism, left auricular thrombus, stent thrombosis, stent stenosis and stent endothelial hyperplasiastent, etc. | From 1 year to 2 years after enrollment |
Before and after NOACs or ticagrelor administration, detect the expression level of RNA in platelet and white blood cell . |
| NOACs: Once each before administration, before and after administration at stable concentration (at least 48h for rivaroxaban, 72h for apixaban or edoxaban). Ticagrelor: Once before administration and once after stable concentration (at least 48h). |
| Anticoagulantion activity evaluation (for NOACs only) | Before and after NOACs administration, record anti-factor Xa activity(for rivaroxaban, apixaban, edoxaban) or anti-factor IIa activity (for dabigatran only) detected by blood coagulation tests. | Once each before administration, before and after administration at stable concentration (at least 48h for rivaroxaban, 72h for apixaban or edoxaban) . |
| Platelet reactivity evaluation (for Ticagrelor only) | Before and after ticagrelor administration, record PRI detected by one or more following methods: 1)LTA; 2)VASP ELISA test; 3)TEG. | Once before administration and once after stable concentration. |
| Peking University First Hospital | Beijing | Beijing Municipality | China |
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| The Second Affiliated Hospital Of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
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| The 7th People's Hospital of Zhengzhou | Zhengzhou | Henan | China |
|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | China |
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| Zhongshan Hospital FuDan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010976 | Platelet Count |
| D007958 | Leukocyte Count |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D010979 | Platelet Function Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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