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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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07774273). StuddyBuddy aggregates publicly available trial information.