[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"noacs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:noacs":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100588922","safety-and-efficacy-of-edoxaban-and-rivaroxaban-to-cerebral-venous-thrombosis-in-chinese-patients-100588922",false,"NCT06947707","Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients","Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Patient aged from 18 to 80 years and no gender preference;\n2. Diagnosis of CVT as confirmed on MRBTI\u002FMRV or CT\u002FCTV or DSA;\n3. Acute or subacute CVT from onset to door within 4 weeks;\n4. The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;\n5. Patient or legally authorized representative is able to give written informed consent.\n\nExclusion Criteria:\n\n1. Patient refuse to take edoxaban or rivaroxaban to treat CVT;\n2. Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;\n3. Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;\n4. CVT secondary to central nervous system infection or severe head trauma;\n5. It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;\n6. Bleeding diathesis or other contraindication to anticoagulation;\n7. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use;\n8. Concomitant use of strong CYP3A4 or P-gp inhibitors;\n9. Impaired renal function (CrCl\\\u003C30 mL\u002Fmin using Cockcroft-Gault equation) or investigator anticipate the CrCl lower than 30 mL\u002Fmin during study;\n10. Impaired liver function (ALT or AST exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently;\n11. Patient is unable to swallow due to depressed level of consciousness or other reasons;\n12. Patient has a severe or fatal comorbid illness with life expectancy less than 6 months;\n13. Patient with severe hypertension (SBP≥180mmHg and\u002For DBP≥110mmHg);\n14. Patient is known to be allergic to edoxaban or rivaroxaban.","ALL","18 Years","80 Years",{"count":20,"type":21},1486,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (CVT). The main question it aims to answer are:\n\n* Do cerebral veins or venous sinuses recanalize during the treatment period of edoxaban and rivaroxaban?\n* Do the bleeding events occur during the treatment period of edoxaban and rivaroxaban?\n\nThe main tasks participants will be asked to do:\n\n* Participants will comply fully with the prescribed regimen and take the edoxaban or rivaroxaban as directed at the specified dosage.\n* Participants will return to hospital for scheduled follow-up assessments at months 3, 6, 9, and 12 post-enrollment to undergo face-to-face visits with investigators.",[25,26,27,28,29,30,31,32,33],"Cerebral Venous Thrombosis","Anticoagulants and Thrombotic Disorders","Anticoagulation Treatment","Anticoagulant Therapy","Anticoagulant Drugs","NOACs","Anticoagulant Prophylaxis\u002FTherapy","Anticoagulation With NOAC","Anticoagulation With Direct Oral Anticoagulants","RECRUITING","2025-04-20",{"date":37,"type":38},"2025-04-27","ACTUAL",{"date":40,"type":38},"2025-04-10",{"date":42,"type":21},"2027-12-31",{"name":44,"class":45},"Xuanwu Hospital, Beijing","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100497984","imapct-of-biomarkers-on-pharmacodynamics-and-bleeding-risk-of-direct-oral-anticoagulants-and-ticagrelor-study-ii-100497984","NCT05764356","Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II","Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II (IMPACT 2)","Inclusion Criteria:\n\n(I) Chinese Patients taking NOACs\n\n* In accordance with anticoagulation indications of NOACs, include prevention of thrombosis in non valvular atrial fibrillation, prevention and treatment of deep vein thrombosis \u002F pulmonary embolism and prevention of thrombosis after knee \u002F hip replacement;\n* More than 18 years of age, male or female;\n* Never received NOACs in a month and intend to take NOACs or have received NOACs for more than one week continuously;\n* sign informed consent.\n\n(II) Chinese Patients taking ticagrelor\n\n* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;\n* More than 18 years of age, male or female;\n* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously#\n* sign informed consent.\n\nExclusion Criteria:\n\n* With history of immunodeficiency disease, including positive HIV index;\n* Positive Hepatitis B surface antigen (HBsAg) and HCV index;\n* 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;\n* Severe liver dysfunction and abnormal renal function;\n* 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.",{"count":55,"type":21},2000,"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.",[58,30,59,60,61,62,63,64,65,66,67,68],"Novel Oral Anticoagulants","Rivaroxaban","Apixaban","Edoxaban","Dabigatran","Ticagrelor","Pharmacodynamics","Pharmacogenomics","RNA Profile","Bleeding","Biomarker","NOT_YET_RECRUITING","2023-03-01",{"date":72,"type":38},"2023-03-10",{"date":74,"type":21},"2023-03",{"date":76,"type":21},"2027-12",{"name":78,"class":45},"Peking University First Hospital",6]