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Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism
Sponsor: Combined military hospital lahore
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.
Official title: Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism: A Single-Center Randomized Controlled Trial in Pakistan
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2021-01-01
Completion Date
2026-02-15
Last Updated
2026-08-24
Healthy Volunteers
No
Interventions
Drug: Apixaban
Participants assigned to this arm will receive apixaban administered orally according to the standard acute-treatment regimen for venous thromboembolism
Drug: Rivaroxaban
Participants assigned to this arm will receive rivaroxaban administered orally according to the standard acute-treatment regimen for venous thromboembolism.
Locations (1)
Combined Military Hospital Lahore
Lahore, Punjab Province, Pakistan