Pulmonary Embolism AcuteAPIX-PE (ApixaNCT07774273
Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism
A study testing Drug: Apixaban and Drug: Rivaroxaban in people with Pulmonary Embolism Acute and Venous Thromboembolism (VTE), run by Combined military hospital lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism Acute, Venous Thromboembolism (VTE)
- What is being tested?
- Drug: Apixaban and Drug: Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT pulmonary angiography-confirmed acute PE
- Intraluminal pulmonary arterial filling defect
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Combined Military Hospital Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism: A Single-Center Randomized Controlled Trial in Pakistan
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
- Being tested
- Drug: Apixaban, Drug: Rivaroxaban
- Keywords
- Apixaban, Rivaroxaban, Direct Oral Anticoagulants, Clinically Relevant Bleeding Major Bleeding
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: ApixabanDrug
Participants assigned to this arm will receive apixaban administered orally according to the standard acute-treatment regimen for venous thromboembolism
Drug: RivaroxabanDrug
Participants assigned to this arm will receive rivaroxaban administered orally according to the standard acute-treatment regimen for venous thromboembolism.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Participants will receive 10 mg twice daily for 7 days, then 5 mg twice daily for 3 months total Receives: Drug: Drug: Apixaban |
| Rivaroxaban | Active comparator | Participants will receive 15 mg twice daily for 21 days, then 20 mg once daily for 3 months total Receives: Drug: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major or CRNM bleeding
Number of patients with ISTH-defined major bleeding or clinically relevant non-major bleeding will be assessed
Measured: 3 months
Secondary outcomes (1)
Major bleeding
Number of patients with ISTH-defined major bleeding will be evaluated
Measured: 03 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined military hospital lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Kashif, Combined military hospital lahore
- Investigators
- Ayyaz Ahmad, MBBS, FCPS, Study director, Combined military hospital lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774273
- Sponsor's protocol ID
- CMH34
- Acronym
- APIX-PE (Apixa
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism: A Single-Center Randomized Controlled Trial in Pakistan
- ClinicalTrials.gov ID
- NCT07774273
- Acronym / sponsor ID
- APIX-PE (Apixa / CMH34
- Keywords
- Apixaban, Rivaroxaban, Direct Oral Anticoagulants, Clinically Relevant Bleeding Major Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Combined military hospital lahoreUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Drug: ApixabanParticipants will receive 10 mg twice daily for 7 days, then 5 mg twice daily for 3 months total |
| Rivaroxaban | Active comparator | Drug: Drug: RivaroxabanParticipants will receive 15 mg twice daily for 21 days, then 20 mg once daily for 3 months total |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CT pulmonary angiography-confirmed acute PE
- Intraluminal pulmonary arterial filling defect
Key exclusion criteria (7 listed)
- Hemophilia or other bleeding disorder
- Known platelet disorder
- Previous major bleeding
- Active bleeding
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: ApixabanParticipants assigned to this arm will receive apixaban administered orally according to the standard acute-treatment regimen for venous thromboembolism | Drug | Apixaban |
| Drug: RivaroxabanParticipants assigned to this arm will receive rivaroxaban administered orally according to the standard acute-treatment regimen for venous thromboembolism. | Drug | Rivaroxaban |
Primary outcome
Composite of major or CRNM bleeding
Time frame: 3 months
Number of patients with ISTH-defined major bleeding or clinically relevant non-major bleeding will be assessed
1 secondary outcome
Major bleeding
Time frame: 03 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayyaz Ahmad, MBBS, FCPS study director
Combined military hospital lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug: Apixaban and Drug: Rivaroxaban in people with Pulmonary Embolism Acute and Venous Thromboembolism (VTE), run by Combined military hospital lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major or CRNM bleeding (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.