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Enrolling by Invitation

NCT Number: NCT07654634

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Not applicable- observational study

Other

not have

Primary outcomes

  1. Efficacy Endpoint: Composite thrombotic events (ischemic stroke, systemic embolism, myocardial infarction, deep vein thrombosis, pulmonary embolism)

    Time frame: At the 1st month, 3rd month and 6th month after enrollment

  2. Safety Endpoint: Bleeding events (major bleeding and clinically relevant non-major bleeding)

    Time frame: At the 1st month, 3rd month and 6th month after enrollment

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • Changsha Central Hospital
  • Changsha First Hospital
  • Eastern Theater Command General Hospital
  • Fengxian District Central Hospital of Shanghai
  • First Affiliated Hospital of Xinjiang Medical University
  • Fudan University Affiliated Shanghai Fifth People's Hospital Hospital
  • Hengyang Central Hospital
  • Huashan Hospital
  • Hunan Aerospace Hospital
  • Hunan Cancer Hospital
  • Hunan Medical College General Hospital
  • Hunan Provincial Maternal and Child Health Care Hospital
  • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
  • Hunan Provincial Rehabilitation Hospital
  • Jining Medical College Affiliated Hospital
  • Jinshan Hospital Affiliated to Fudan University
  • Renji Hospital Pu Nan Branch, Affiliated to Shanghai Jiao Tong University School of Medicine
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
  • Second Affiliated Hospital of Shaoyang University
  • Shanghai East Hospital
  • Shanghai Minhang District Central Hospital
  • Shanghai Yangpu District Shidong Hospital
  • Shenzhen Second People's Hospital
  • Taoyuan County People's Hospital
  • The First Affiliated Hospital of Dalian Medical University
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Nanhu University
  • The First Affiliated Hospital of Naval Medical University
  • The First Affiliated Hospital of Shaoyang University of Science and Technology
  • The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine
  • The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • The Second Affiliated Hospital of Nanhu University
  • Xiangtan Central Hospital
  • Xiangtan County People's Hospital
  • Xiangya Changde Hospital
  • Yongzhou Central Hospital
  • Yueyang Central Hospital

Registry information

Official study title

A Multicenter Cohort Study on Precision Antithrombotic Therapy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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