Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

What this study is about

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

Who can join (things the study team will check)

✅ You may be able to join if…

• Age > 18 years
• Symptomatic atherosclerotic LE PAD fulfilling at least one of the following: a. Intermittent claudication with ankle/arm blood pressure ratio* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. >1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR < 60 mL/min/1.73 m2) b. Rest pain (mostly in foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio* (ABI ≤ 0.90) OR artery stenosis ≥ 50%. c. Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery d. Leg or foot amputation for arterial vascular indications
  • In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable
• Written or verbal informed consent from the patient

🚫 You may not be able to join if…

• Contraindication to colchicine
• Long term requirement for colchicine for another clinical indication
• Active diarrhoea
• eGFR < 30 mL/min/1.73 m2
• Cirrhosis or severe chronic liver disease
• Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
• Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)
• Patients who are deemed unlikely to return for follow-up
• Patients with life expectancy < 1 year

Where this trial is running

• Yale School of Medicine, New Haven, Connecticut, United States
• University of Florida - Gainesville, Gainesville, Florida, United States
• Tampa General Hospital, Tampa, Florida, United States
• University of Chicago Medical Center, Chicago, Illinois, United States
• Henry Ford Health System, Detroit, Michigan, United States
• Mayo Clinic, Rochester, Minnesota, United States
• Rutgers University, Newark, New Jersey, United States
• University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
• Duke Regional Hospital, Durham, North Carolina, United States
• Duke University Medical Center, Durham, North Carolina, United States
• Duke Raleigh Hospital, Raleigh, North Carolina, United States
• Ohio State University Wexner Medical Center, Columbus, Ohio, United States

+ 58 more sites.

Who to contact

Noel C Chan, MD · 905-521-2100 · Noel.Chan@TAARI.CA

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04774159.