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

RecruitingEARLY Phase 1Ages 40 Years - 70 YearsAllKing Edward Medical University
NCT07832578 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 assessmen

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📋 Eligibility rules (as published)
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
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What it tests

  • Aspirin tablet
  • Low-Dose Rivaroxaban Plus Aspirin,
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Where

1 site
Mayo Hospital Lahore
Lahore, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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