Limb Ischemia study: Aspirin tablet
Official title Comparison of Aspirin Alone Versus Low-Dose Rivaroxaban Plus Aspirin in Chronic Limb-Threatening Ischemia
ClinicalTrials.gov ID: NCT07832578
What this study is testing
What is Aspirin tablet?
an investigational low-dose tablet being studied as a potential treatment for chronic limb‑threatening ischemia is designed to inhibit platelet aggregation by blocking the cyclooxygenase enzyme
Also referred to as acetylsalicylic acid.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding low‑dose rivaroxaban to aspirin lowers serious leg problems, heart attacks, strokes, and improves healing compared to aspirin alone.
- Who it's for
- Adults aged 40‑70 who have chronic limb‑threatening ischemia and also have diabetes, high blood pressure, and high cholesterol.
- What's involved
- You will be randomly assigned to take either rivaroxaban (2.5 mg twice daily) with aspirin (75‑100 mg daily) or aspirin alone, have blood tests, ankle‑brachial index or toe‑brachial index measurements, and Doppler scans, plus follow‑up visits to check leg health, heart events, and side effects.
- Time commitment
- The trial lasts about 6 months with several scheduled clinic visits for assessments and blood work.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- 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 )
You likely can't join if
- 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
See the full eligibility 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 treatment studies)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Lahore, Punjab Province, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Lahore, Punjab Province, Pakistan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.