Aspirin alone vs. low-dose rivaroxaban plus aspirin for chronic limb-threatening ischemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this early-phase randomized study, adults with chronic limb-threatening ischemia are assigned to receive either low-dose rivaroxaban (2.5 mg twice daily) plus aspirin or aspirin alone for six months. Participants undergo baseline assessments including blood tests, ABPI/TBI, and Doppler studies, and are then monitored for major adverse limb events and major adverse cardiovascular events. The aim is to determine if the combination therapy improves limb outcomes and reduces cardiovascular events compared with aspirin alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Hospital Lahore
  Lahore, Punjab Province, Pakistan Recruiting

Study contacts

• Study coordinator: Hafsa Farooq, MBBS
• Email: hafsafarooqiqbal.99@gmail.com
• Phone: +923335700188

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Feasibility of paired non-invasive blood flow and tissue oxygen monitoring to detect limb ischemia during lithotomy-position surgeries

  This study tests whether using combined non-invasive blood flow monitoring and tissue oxygen sensors during long lithotomy surgeries can help detect early limb ischemia in adults.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas and 1 other locations · NCT07387653

• Monitoring leg pressure in patients on ECMO to prevent compartment syndrome

  This study is testing a new device that continuously checks leg pressure in patients on ECMO to see if it helps prevent serious leg problems better than regular methods.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT05830721

• Predictors of Major Adverse Limb Events After Iliac Artery Stenting

  This study tests what factors predict serious limb-related problems after iliac artery stenting in adults with peripheral artery disease.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan, Mi · NCT07672249

• Colchicine for people with severe limb-threatening leg artery disease

  A low-dose colchicine pill is being tested to see if it can help people with chronic limb-threatening ischemia avoid worsening of their leg condition and improve outcomes.

  Recruiting at 2 sites Phase 3 Shin Kong Wu Ho-Su Memorial Hospital · Taipei, Taipei and 4 other locations · NCT07536373

• Imaging plaque activity across the body in people with symptomatic peripheral arterial disease

  This project will use whole-body PET-CT and CT angiography with several tracers to see if imaging can detect inflammation, microcalcification, and clot activity in people with symptomatic peripheral arterial disease.

  Recruiting University of Edinburgh · Edinburgh, Midlothian · NCT07472049

• Vessel recoil after below-the-knee revascularization in high-risk CLTI patients

  This study tests how much vessels recoil after a final endovascular treatment in adults with chronic limb-threatening ischemia affecting below-the-knee arteries.

  Recruiting Medical University of Graz · Graz · NCT07465627

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.