ClinicalTrials.gg
CompletedNCT07774273APIX-PE (ApixaUpdated Aug 24, 2026

Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism

An interventional study of Drug: Apixaban and Drug: Rivaroxaban in Pulmonary Embolism Acute and Venous Thromboembolism (VTE), sponsored by Combined military hospital lahore. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Combined military hospital lahore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Jan 2021, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
540
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies testing apixaban in Venous Thromboembolism — 11 open to participants now, 11 under way, 1 of them phase 3. apixaban · Venous Thromboembolism.

Enrollment
12th of 37
540 · median 100
Started
2021
with 3 others
No phase
4 of 37
2 open now
Registered
35th of 37
by date
Lead sponsor
1 of 37
Combined military hospital lahore

Among the 37 studies testing apixaban in Venous Thromboembolism, this one is the 12th largest by enrollment, is one of 4 that started in 2021, is one of 4 with no phase, and was the 35th registered.

By phase

37 studies; the count open now beside each. This study's row is marked.

Phase 414 · 5 open
Phase 27 · 1 open
Phase 15 · 2 open
Phase 35 · 1 open
No phasethis study4 · 2 open
Phase 1/21 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2011; this study’s year is marked. 4 started in 2021.

Size and results

Median enrollment 100 across the 37 interventional studies. Of the 25 that completed or were terminated, 12 (48%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 37 studies testing apixaban in Venous Thromboembolism, or all of them as a file.
02

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.

Read the detailed description

Background: Direct oral anticoagulants (DOACs) are recommended for most eligible patients with acute venous thromboembolism, but comparative bleeding data for apixaban versus rivaroxaban in South Asian populations remain limited. This study will address this knowledge gap by providing direct randomized evidence from a Pakistani cohort.

Study Design: Single-center, prospective, open-label, randomized controlled trial with 1:1 allocation.

Interventions:

Apixaban Group: 10 mg twice daily for 7 days, followed by 5 mg twice daily for the remainder of 3 months

Rivaroxaban Group: 15 mg twice daily for 21 days, followed by 20 mg once daily for the remainder of 3 months

Follow-up Duration: 3 months with monthly assessments

Primary Endpoint: Composite of major bleeding or clinically relevant non-major (CRNM) bleeding within 3 months

Secondary Endpoints: (To be confirmed against protocol)

Major bleeding alone

CRNM bleeding alone

Recurrent venous thromboembolism

All-cause mortality

03

Conditions studied

  • Pulmonary Embolism Acute
  • Venous Thromboembolism (VTE)

Keywords

  • Apixaban
  • Rivaroxaban
  • Direct Oral Anticoagulants
  • Clinically Relevant Bleeding Major Bleeding
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • CT pulmonary angiography-confirmed acute PE
  • Intraluminal pulmonary arterial filling defect

Exclusion criteria

Exclusion Criteria:

  • Hemophilia or other bleeding disorder
  • Known disorder
  • Previous major bleeding
  • Active bleeding
  • Pregnancy or lactation
  • \< 30 mL/min
  • Indication for therapeutic anticoagulation other than VTE
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
540 participants (actual)

Study arms

  • Experimental
    Apixaban

    Participants will receive 10 mg twice daily for 7 days, then 5 mg twice daily for 3 months total

    Drug: Drug: Apixaban

  • Active comparator
    Rivaroxaban

    Participants will receive 15 mg twice daily for 21 days, then 20 mg once daily for 3 months total

    Drug: Drug: Rivaroxaban

Interventions

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

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

06

What researchers measure

Primary outcomes

  1. Composite of major or CRNM bleeding

    Number of patients with ISTH-defined major bleeding or clinically relevant non-major bleeding will be assessed

    Time frame: 3 months

Secondary outcomes

  1. Major bleeding

    Number of patients with ISTH-defined major bleeding will be evaluated

    Time frame: 03 months

07

Study locations

1 site
  • Combined Military Hospital Lahore
    Lahore, Punjab Province 54000, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared due to institutional restrictions and ethical considerations. The data will be considered proprietary to Army Cardiac Center, Lahore, Pakistan, and will be subject to institutional data governance policies that prioritize patient confidentiality. The ethics committee approval for this study does not include provisions for sharing de-identified participant data with external researchers. Furthermore, Pakistan's data protection regulations and institutional review board requirements will mandate that all participant-level data remain securely stored within the institution and accessible only to authorized study personnel. Sharing will be further limited because the open-label, single-center design and small number of bleeding events will make the data potentially identifiable even after de-identification. However, aggregated summary statistics, baseline characteristics tables, and fully de-identified outcome data will be made availab

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07774273
Lead sponsor
Combined military hospital lahore
Responsible party
Muhammad Kashif (Principal investigator, Combined military hospital lahore) — Principal investigator
First posted
Aug 19, 2026
Start date
Jan 1, 2021
Primary completion
Dec 31, 2025
Completion
Feb 15, 2026
Last update
Aug 24, 2026

Study contacts

Ayyaz Ahmad, MBBS, FCPS
study director · Combined military hospital lahore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Apixaban

Start the discussion