Aspirin alone versus aspirin with low-dose rivaroxaban for severe leg artery blockage
Compares two blood-thinning treatments in people with severe limb ischemia, diabetes, hypertension and high cholesterol.
Plain-language title generated from the registry record
Registry title: Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia
Key facts
- Where
- Lahore, PakistanSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
Source: NCT07832578, who can take part
Where in Pakistan
- Mayo Hospital LahoreLahore, PakistanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- King Edward Medical University
- Trial code
- NCT07832578
- Record updated
- 22 September 2026
- Original description
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:Read full original descriptionShow less
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?
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.
Inclusion: 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 ); ABPI < 0.6; Claudication distance < 100 meters; Provided written informed consent (for prospective or interventional studies).
Exclusion: Previous amputation or debridement of vascular ulcers; Recent major surgery (<1 month); History of SEPS(subfacial endoscopic perforator surgery); Active bleeding disorder; Renal failure requiring dialysis; HbA1c >12 mg/dl; Cholesterol >300mg/dl; Diagnosed varicose veins; Coagulopathy; Pregnancy or breastfeeding.