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Recruiting

NCT Number: NCT06362343

The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics

1. Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs). 2. Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes. 3. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process.

Recruiting

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with acute symptomatic pulmonary embolism objectively diagnosed by imaging (with or without deep vein thrombosis) who have completed anticoagulation for the acute phase and have entered the maintenance phase of anticoagulation
  • Expected lifespan greater than 3 months
  • Eligible for the use of Xa factor inhibitors;
  • Agreement to participate in the study, signing of informed consent, and commitment to regular follow-up.

Exclusion criteria

  • Moderate or severe liver dysfunction (Child-Pugh grade B or C);
  • Severe renal impairment (CrCl < 15 ml/min);
  • Pregnant or breastfeeding women;
  • Tendency for spontaneous bleeding, such as coagulopathy or thrombocytopenia (PLT < 20×10^9/L);
  • Contraindications for the use of other Xa factor inhibitors;
  • Patients diagnosed with hereditary thrombophilia and antiphospholipid syndrome.

Treatment and study plan

Rivaroxaban

Drug

Rivaroxaban

Primary outcomes

  1. Bleeding events

    Time frame: Through the entire follow-up time, 3 months

    Major bleeding events, clinical relatied non-major bleeding events and minor bleeding events

  2. Recurrent thromboembolic events

    Time frame: Through the entire follow-up time, 3 months

    Recurrent thromboembolic events

Study contacts

Contact information is provided by the study sponsor or research team.

juhong Shi, M.D

CONTACT

[email protected]

+8613701178492

yiyao Li, M.D

CONTACT

[email protected]

18510797366

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • China-Japan Friendship Hospital
  • Ruijin Hospital
  • Xiangya Hospital of Central South University

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 12, 2024
Registry last updated
Apr 12, 2024

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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