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.
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)
Cholesterol >300mg/dl
HbA1c >12 mg/dl
Previous amputation or debridement of vascular ulcers
Diagnosed varicose veins
Parallel
Aspirin tablet
Drug75 mg once daily
Low-Dose Rivaroxaban Plus Aspirin,
DrugLow 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.
Major Adverse Limb Events (MALEs)
Major Adverse Cardiovascular Events
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