- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Hunan
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Changsha, Hunan, 중국, 410000
- Xiangya Third Hospital of Central South University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Efficacy Endpoint: Composite thrombotic events (ischemic stroke, systemic embolism, myocardial infarction, deep vein thrombosis, pulmonary embolism)
기간: 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)
기간: 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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공동 작업자 및 조사자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- fast26359
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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허혈성 뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병