- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07654634
Precision Antithrombotic Therapy
A Multicenter Cohort Study on Precision Antithrombotic Therapy
The goal of this observational study is to systematically analyze the relationship between trough/peak concentrations of novel oral anticoagulants (NOACs) and antiplatelet drugs with clinical events, aiming to provide high-level evidence for therapeutic drug monitoring (TDM) and personalized dosing.The main questions it aims to answer are:
- What are the optimal preventive and therapeutic concentration ranges for different NOACs (rivaroxaban, apixaban, dabigatran, edoxaban) and antiplatelet drugs (aspirin, indobufen)?
- What are the key factors influencing the blood drug concentrations of NOACs and antiplatelet drugs (such as liver and kidney function, age, weight, concomitant medications)?
- How can we establish a model to predict blood drug concentrations of NOACs and antiplatelet drugs and their related clinical events? Participants will receive routine clinical care. During treatment, blood samples will be regularly collected to measure patients' blood drug concentrations (Ctrough and Cmax), and clinical responses and adverse events will be recorded.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Hunan
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Changsha, Hunan, Porcelana, 410000
- Xiangya Third Hospital of Central South University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
The study enrolls two distinct patient populations:
Thrombotic Disease Patients (4,000 subjects):
Age ≥ 8 years
Diagnosed with one of the following conditions requiring long-term anticoagulation:
Non-valvular atrial fibrillation (CHA₂DS₂-VA score ≥ 1) Venous thromboembolism (deep vein thrombosis or pulmonary embolism) Other indications for NOACs in thrombotic disease prevention/treatment Currently receiving NOAC therapy (rivaroxaban, apixaban, dabigatran, or edoxaban) Willing and able to comply with study protocol and follow-up schedule Signed informed consent
Ischemic Stroke Patients (1,000 subjects):
Age ≥ 18 years Assessed as high bleeding risk within 72 hours after symptom onset First-time treatment with indobufen after hospital admission Willing and able to comply with study protocol and follow-up schedule Signed informed consent
Descripción
Inclusion criteria:
- Age ≥ 8 years old;
- Diagnosed with one of the following diseases and in need of long - term anticoagulant therapy: non - valvular atrial fibrillation (CHA₂DS₂ - VA score ≥ 1); venous thromboembolism (deep vein thrombosis or pulmonary embolism); having other indications for using NOACs to prevent and treat thrombotic diseases;
- Currently receiving NOAC treatment (rivaroxaban, apixaban, dabigatran etexilate, edoxaban);
- Willing and able to comply with the requirements of the research protocol and the follow - up plan;
- Signed the informed consent form.
- Age ≥ 18 years old;
- Assessed as patients at high risk of bleeding within 72 hours after the onset of symptoms;
- Receiving indobufen treatment for the first time after admission;
- Willing and able to comply with the requirements of the research protocol and the follow - up plan;
- Signed the informed consent form.
Exclusion criteria:
- Having contraindications to the use of NOACs or being allergic to NOACs;
- Having been enrolled in other clinical trials.
- Being allergic to or having contraindications to indobufen;
- Needing to change antithrombotic drugs or combine with other antiplatelet/anticoagulant therapies (such as clopidogrel, ticagrelor, warfarin, heparin, etc.) during the study;
- Cardiogenic stroke or stroke induced by angioplasty/vascular surgery;
- Having a history of aneurysm (intracranial or peripheral);
- Severe abnormal liver and kidney functions;
- Pregnant, lactating women or women of childbearing age who are unwilling to take effective contraceptive measures;
- Life expectancy < 1 year;
- Mental or emotional disorders preventing cooperation with follow - up;
- Participating in other clinical trials within 30 days before enrollment;
- Unable to complete blood concentration detection (such as difficulty in establishing venous access).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Efficacy Endpoint: Composite thrombotic events (ischemic stroke, systemic embolism, myocardial infarction, deep vein thrombosis, pulmonary embolism)
Periodo de tiempo: At the 1st month, 3rd month and 6th month after enrollment
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At the 1st month, 3rd month and 6th month after enrollment
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Safety Endpoint: Bleeding events (major bleeding and clinically relevant non-major bleeding)
Periodo de tiempo: At the 1st month, 3rd month and 6th month after enrollment
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At the 1st month, 3rd month and 6th month after enrollment
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Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Infarto
- Necrosis
- Embolia y Trombosis
- Isquemia miocardica
- Isquemia
- Carrera
- Tromboembolismo
- Condiciones Patológicas, Signos y Síntomas
- Accidente cerebrovascular isquémico
- Infarto de miocardio
- Tromboembolismo venoso
Otros números de identificación del estudio
- fast26359
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .