Pulmonary Embolism Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
juhong Shi, M.D
shijh@pumch.cn
+8613701178492
Backup
yiyao Li, M.D
yiyo927@163.com
18510797366
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 300
Treatments
Patients with pulmonary embolism and using direct oral anticoagulants
Patients with pulmonary embolism and using direct oral anticoagulants
Related Therapeutic Areas
Sponsors
Collaborators: China-Japan Friendship Hospital, Ruijin Hospital, Xiangya Hospital of Central South University
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov