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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Enrolling

Conditions

Pulmonary Embolism

Treatments

Drug: Rivaroxaban

Study type

Observational

Funder types

Other

Identifiers

NCT06362343
PUMCH-Rivaroxaban-Monitoring

Details and patient eligibility

About

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). Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Patients with pulmonary embolism and using direct oral anticoagulants
Description:
Patients with pulmonary embolism and using direct oral anticoagulants
Treatment:
Drug: Rivaroxaban

Trial contacts and locations

1

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Central trial contact

juhong Shi, M.D; yiyao Li, M.D

Data sourced from clinicaltrials.gov

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