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

Launched by POPULATION HEALTH RESEARCH INSTITUTE · Feb 24, 2021

Keywords

ClinConnect Summary

The LEADER-PAD trial is studying whether a low dose of colchicine, a medication that reduces inflammation, can help prevent serious health issues in patients with peripheral artery disease (PAD). PAD is a condition where narrowed arteries in the legs can cause pain and other problems. This clinical trial is looking for adults aged 18 and older who have symptoms of PAD, such as pain in the legs when walking, pain at rest, or even severe issues like gangrene or the need for surgery on their legs due to poor blood flow.

If you qualify and decide to participate, you will receive the study medication and be monitored closely by the research team. They will check to see if colchicine can lower the risk of heart attacks, strokes, or other vascular events in patients like you. It’s important to note that some individuals, like those with certain health conditions or medications, may not be eligible for this trial. If you’re interested, the team will provide detailed information and support to help you understand your options.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Age \> 18 years
• 2. 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%.
• • \* In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable
• • 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
• • 3. Written or verbal informed consent from the patient
• Exclusion Criteria:
• • 1. Contraindication to colchicine
• • 2. Long term requirement for colchicine for another clinical indication
• • 3. Active diarrhoea
• • 4. eGFR \< 30 mL/min/1.73 m2
• • 5. Cirrhosis or severe chronic liver disease
• • 6. Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
• • 7. Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)
• • 8. Patients who are deemed unlikely to return for follow-up
• • 9. Patients with life expectancy \< 1 year