Actively Recruiting
The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
Led by Peking Union Medical College Hospital · Updated on 2024-04-12
300
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with acute symptomatic pulmonary embolism confirmed by imaging who have completed anticoagulation for the acute phase and entered the maintenance phase
- Expected lifespan longer than 3 months
- Eligible for use of Xa factor inhibitors
- Agree to participate, sign informed consent, and commit to regular follow-up
You will not qualify if you...
- Moderate or severe liver dysfunction (Child-Pugh grade B or C)
- Severe renal impairment (creatinine clearance less than 15 ml/min)
- Pregnant or breastfeeding women
- Spontaneous bleeding tendency such as coagulopathy or thrombocytopenia (platelet count less than 20 x 10^9/L)
- Contraindications to other Xa factor inhibitors
- Diagnosed with hereditary thrombophilia or antiphospholipid syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
juhong Shi, M.D
CONTACT
Y
yiyao Li, M.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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