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Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia
Sponsor: King Edward Medical University
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\*\*. 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.
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
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2026-06-01
Completion Date
2027-04-01
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Aspirin tablet
75 mg once daily
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.
Locations (1)
Mayo Hospital Lahore
Lahore, Punjab Province, Pakistan