Limb IschemiaEarly Phase 1NCT07832578
Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia
A Early Phase 1 study testing Aspirin tablet and Low-Dose Rivaroxaban Plus Aspirin, in people with Limb Ischemia, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the effectiveness of low-dose rivaroxaban plus aspirin versus aspirin alone in patients aged 40-70 years with chronic limb-threatening ischemia, diabetes mellitus, hypertension, and hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Limb Ischemia
- What is being tested?
- Aspirin tablet and Low-Dose Rivaroxaban Plus Aspirin,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 Apr 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of CLTI managed conservatively
- ASA score of 3 or more
- Age 40-70 yrs
- Diagnosed case of Diabetes mellitus type 2 (HbA1c >8)
- Blood Pressue ( >130/90 , <180/100 )
- Hypercholestrolemia (Total cholesterol ≥200 mg/dL )
Show all 9Show fewer
- ABPI < 0.6
- Claudication distance < 100 meters
- Provided written informed consent (for prospective or interventional studies)
Who cannot join
- Cholesterol >300mg/dl
- HbA1c >12 mg/dl
- Previous amputation or debridement of vascular ulcers
- Diagnosed varicose veins
- History of SEPS(subfacial endoscopic perforator surgery)
- Active bleeding disorder
Show all 10Show fewer
- Recent major surgery (<1 month)
- Renal failure requiring dialysis
- Coagulopathy
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Hafsa Farooq, MBBS, +923335700188, hafsafarooqiqbal.99@gmail.com
About this study
Official title: Comparison of Outcomes of Chronic Limb Threatening Ischemia in Diabetic and Hypertensive Patients With Hypercholesterolemia: Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin, in Mayo Hospital, Lahore
The goal of this clinical trial is to compare the effectiveness of low-dose rivaroxaban plus aspirin versus aspirin alone in patients aged 40-70 years with chronic limb-threatening ischemia, diabetes mellitus, hypertension, and hypercholesterolemia. The main questions it aims to answer are:
- Does low-dose rivaroxaban plus aspirin reduce major adverse limb events (MALE), such as acute limb ischemia and amputation?
- Does the combination therapy reduce major adverse cardiovascular events (MACE), such as myocardial infarction and stroke, and improve limb-related outcomes?
Read more
Researchers will compare low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (75-100 mg daily) with aspirin alone to see if combination therapy provides better outcomes over a period of 6 months.
Participants will:
- Undergo baseline clinical assessment, blood tests, ABPI/TBI, and Doppler/duplex assessment.
- Be randomly assigned to either the rivaroxaban plus aspirin group or the aspirin-alone group.
- Attend follow-up visits at specified intervals for assessment of WIFI score, ABPI, wound healing, MALE, MACE, and quality of life.
- Be assessed for treatment compliance, side effects, and bleeding during follow-up.
- Conditions
- Limb Ischemia
- Being tested
- Aspirin tablet, Low-Dose Rivaroxaban Plus Aspirin,
- Keywords
- aspirin, Low-Dose Rivaroxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin tabletDrug
75 mg once daily
Low-Dose Rivaroxaban Plus Aspirin,Drug
Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Not described Receives: Drug: Aspirin tablet |
| Low-Dose Rivaroxaban and Aspirin, | Active comparator | Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose. Receives: Drug: Low-Dose Rivaroxaban Plus Aspirin, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Limb Events (MALEs)
Measured: 6 months
Major Adverse Cardiovascular Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb IschemiaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, javeria khalid, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832578
- Sponsor's protocol ID
- 1213/ARA/KEMU/26
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Chronic Limb Threatening Ischemia in Diabetic and Hypertensive Patients With Hypercholesterolemia: Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin, in Mayo Hospital, Lahore
- ClinicalTrials.gov ID
- NCT07832578
- Acronym / sponsor ID
- 1213/ARA/KEMU/26
- Conditions
- Limb Ischemia
- Keywords
- aspirin, Low-Dose Rivaroxaban
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Sep 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.
The goal of this clinical trial is to compare the effectiveness of low-dose rivaroxaban plus aspirin versus aspirin alone in patients aged 40-70 years with chronic limb-threatening ischemia, diabetes mellitus, hypertension, and hypercholesterolemia. The main questions it aims to answer are:
- Does low-dose rivaroxaban plus aspirin reduce major adverse limb events (MALE), such as acute limb ischemia and amputation?
- Does the combination therapy reduce major adverse cardiovascular events (MACE), such as myocardial infarction and stroke, and improve limb-related outcomes?
Researchers will compare low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (75-100 mg daily) with aspirin alone to see if combination therapy provides better outcomes over a period of 6 months.
Participants will:
- Undergo baseline clinical assessment, blood tests, ABPI/TBI, and Doppler/duplex assessment.
- Be randomly assigned to either the rivaroxaban plus aspirin group or the aspirin-alone group.
- Attend follow-up visits at specified intervals for assessment of WIFI score, ABPI, wound healing, MALE, MACE, and quality of life.
- Be assessed for treatment compliance, side effects, and bleeding during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin tablet |
| Low-Dose Rivaroxaban and Aspirin, | Active comparator | Drug: Low-Dose Rivaroxaban Plus Aspirin,Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients of CLTI managed conservatively
- ASA score of 3 or more
- Age 40-70 yrs
- Diagnosed case of Diabetes mellitus type 2 (HbA1c >8)
- Blood Pressue ( >130/90 , <180/100 )
Key exclusion criteria (10 listed)
- Cholesterol >300mg/dl
- HbA1c >12 mg/dl
- Previous amputation or debridement of vascular ulcers
- Diagnosed varicose veins
- History of SEPS(subfacial endoscopic perforator surgery)
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 |
|---|---|---|
| Aspirin tablet75 mg once daily | Drug | Aspirin |
| Low-Dose Rivaroxaban Plus Aspirin,Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose. | Drug | Low-Dose Rivaroxaban and Aspirin, |
Primary outcome
Major Adverse Limb Events (MALEs)
Time frame: 6 months
Major Adverse Cardiovascular Events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Limb Ischemia
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Recruiting
Effectiveness of Theta Burst Stimulation For Upper and Lower Extremity Recovery in Stroke
Ischemic Stroke
Not yet recruiting
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
Chronic Stroke, Ischemic Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin tablet and Low-Dose Rivaroxaban Plus Aspirin, in people with Limb Ischemia, run by King Edward Medical University 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 Sep 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafsa Farooq, MBBS (+923335700188, hafsafarooqiqbal.99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Limb Events (MALEs) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 22 Sep 2026.