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

NCT06362343 | Recruiting FDA Drug

• 1 other identifier: PUMCH-Rivaroxaban-Monitoring
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes.
3. 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

Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• Bleeding events

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

  Through the entire follow-up time, 3 months

• Recurrent thromboembolic events

  Recurrent thromboembolic events

  Through the entire follow-up time, 3 months

Study Arms (1)

Patients with pulmonary embolism and using direct oral anticoagulants

Patients with pulmonary embolism and using direct oral anticoagulants

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Rivaroxaban

Patients with pulmonary embolism and using direct oral anticoagulants

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with pulmonary embolism and are using DOACs.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Ruijin Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood（Cells and Plasma）and Urine

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Juhong Shi, M.D

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

juhong Shi, M.D

CONTACT

+8613701178492; shijh@pumch.cn

yiyao Li, M.D

CONTACT

18510797366; yiyo927@163.com

Study Design

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

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)