NCT07654634

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
May 2026Dec 2027

Study Start

First participant enrolled

May 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 17, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

May 18, 2026

Last Update Submit

June 11, 2026

Conditions

Non-valvular Atrial Fibrillation (NVAF)Venous Thromboembolism (VTE)MI(Myocardial Infarction)Ischemic Stroke

Keywords

Precise antithrombotic medicationTherapeutic drug monitoring (TDM)New oral anticoagulants (NOACs)Non-valvular atrial fibrillation (NVAF)

Outcome Measures

Primary Outcomes (2)

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

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

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

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

Interventions

Not applicable- observational studyOTHER

not have

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Third Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and urine samples

MeSH Terms

Conditions

Venous ThromboembolismMyocardial InfarctionIschemic Stroke

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 17, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 17, 2026

Record last verified: 2026-05

Locations

CN(1)