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Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia

Sponsor: King Edward Medical University • ClinicalTrials.gov ID: NCT07832578

Registry updated: 2026-09-22

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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: * 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.

Interventions

Aspirin tablet (Drug)
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.

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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 * Recent major surgery (\<1 month) * Renal failure requiring dialysis * Coagulopathy * Pregnancy or breastfeeding

Conditions

Limb Ischemia

Locations

Mayo Hospital Lahore — Lahore, Punjab Province, Pakistan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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