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Completed
NCT07774273
Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism
Conditions: Pulmonary Embolism Acute, Venous Thromboembolism (VTE)
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 540
Sponsor: Combined military hospital lahore
Location: Combined Military Hospital Lahore Lahore Punjab Province
Summary
This prospective, open-label, randomized controlled trial will compare clinically relevant bleeding during the first three months of treatment with apixaban versus rivaroxaban in adults with acute pulmonary embolism (PE) in a Pakistani cohort. A total of 540 participants will be randomized 1:1 to receive standard acute-treatment regimens of either apixaban or rivaroxaban. The primary outcome will be the composite of major bleeding or clinically relevant non-major (CRNM) bleeding within three months, defined according to International Society on Thrombosis and Haemostasis (ISTH) criteria.
Eligibility Criteria
Inclusion Criteria:
* CT pulmonary angiography-confirmed acute PE
* Intraluminal pulmonary arterial filling defect
Exclusion Criteria:
* Hemophilia or other bleeding disorder
* Known platelet disorder
* Previous major bleeding
* Active bleeding
* Pregnancy or lactation
* Creatinine clearance \< 30 mL/min
* Indication for therapeutic anticoagulation other than VTE
Source: ClinicalTrials.gov (NCT07774273). StuddyBuddy aggregates publicly available trial information.