NCT07832578RecruitingEarly phase 1
Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 7 Sept 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- King Edward Medical University
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07832578
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 78
- From 1 Jun 2026 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous amputation or debridement of vascular ulcers
- Recent major surgery (\<1 month)
Other illness
- History of SEPS(subfacial endoscopic perforator surgery)
- Active bleeding disorder
- Renal failure requiring dialysis
Lab values
- HbA1c \>12 mg/dl
Other
- Cholesterol \>300mg/dl
- Diagnosed varicose veins
- Coagulopathy
- Pregnancy or breastfeeding
Who the study is looking for
- 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)
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Hospital Lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.