Pulmonary Embolism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients with acute symptomatic pulmonary embolism (with or without concurrent deep vein thrombosis) objectively diagnosed by imaging, who have completed the acute phase of anticoagulation and entered the maintenance phase of anticoagulation.
Exclusion criteria
Exclusion criteria: 1. Life expectancy < 3 months; 2. Presence of active major bleeding or obvious bleeding tendency (e.g., recent gastrointestinal bleeding, history of intracranial hemorrhage not assessed as stable, etc.), or judged by the investigator to have unacceptable risk of anticoagulation; 3. Severe liver dysfunction (e.g., Child-Pugh Class C) or significant coagulation abnormalities not attributed to anticoagulation; 4. Severe renal dysfunction (e.g., eGFR < 15 mL/min/1.73m^2 or requiring dialysis) making the use of direct oral anticoagulants (DOACs) inappropriate; 5. Significant thrombocytopenia (e.g., platelet count < 50 × 10^9/L) or other severe hematological disorders affecting bleeding/coagulation assessment; 6. Pregnancy or breastfeeding; 7. Inability to adhere to fixed medication and blood sampling schedules as required by the study (e.g., poor compliance, inability to follow up, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic VTE recurrence;Plasma drug concentration (anti-FXa, Cpeak, Ctrough);Coagulation parameters (PT, Factor Xa activity);Genotype (ABCB1, ABCG2, CYP3A4, CYP3A5 SNPs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatal or non-fatal pulmonary thromboembolism; | — |
Countries
China
Contacts
Peking Union Medical College Hospital