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Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism

NCT07774273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

  • Pulmonary Embolism Acute
  • Venous Thromboembolism (VTE)

Interventions

DRUG

Drug: Apixaban

Participants assigned to this arm will receive apixaban administered orally according to the standard acute-treatment regimen for venous thromboembolism

DRUG

Drug: Rivaroxaban

Participants assigned to this arm will receive rivaroxaban administered orally according to the standard acute-treatment regimen for venous thromboembolism.

Sponsors & Collaborators

  • Combined military hospital lahore

    lead OTHER

Principal Investigators

  • Ayyaz Ahmad, MBBS, FCPS · Combined military hospital lahore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-12-31
Completion
2026-02-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774273 on ClinicalTrials.gov