Monitoring and dosing guidance for anticoagulants in pulmonary embolism patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop a population pharmacokinetic-pharmacodynamic (PK-PD) model for Direct Oral Anticoagulants (DOACs) in patients with pulmonary embolism. It will investigate the factors influencing the PK-PD of DOACs, including the correlation between genetic characteristics and clinical outcomes. The study will also explore the relationship between drug concentrations, coagulation indices, and clinical outcomes to establish effective monitoring and dosing strategies for DOACs.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Juhong Shi, M.D — Peking Union Medical College Hospital
• Study coordinator: juhong Shi, M.D
• Email: shijh@pumch.cn
• Phone: +8613701178492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.