Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk (LEADER-PAD)

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Acute limb ischemia, Myocardial Infarction, Stroke, Cardiovascular death, Mortality Read More

Patients need to meet the following criteria for inclusion:

1. Age > 18 years

2. History of symptomatic lower extremity PAD* with one or more high risk features:

   1. symptomatic lower extremity PAD with one of the following risk factors: [>1 vascular bed affected by atherosclerosis, presence of diabetes, history of heart failure or lower eGFR (< 60 ml/min)]
   2. or prior lower extremity revascularization
   3. or prior limb or foot amputation
   4. or Fontaine 3 or 4 symptoms/signs
3. Written or verbal informed consent from the patient

Note:

* Lower extremity PAD is defined by one or more of the following:

1. presence of intermittent claudication and one or more of ankle/arm blood pressure ratio (ABI) < 0.90 or peripheral artery stenosis >50% documented by angiography or duplex ultrasound; or
2. a history of revascularization defined as limb bypass surgery or percutaneous transluminal angioplasty of iliac or infra-inguinal arteries or extra-anatomical limb bypass surgery; or
3. limb or foot amputation for macrovascular arterial vascular disease

Exclusion Criteria:

1. Contraindication to colchicine
2. Requirement for colchicine for another clinical indication
3. Active diarrhoea
4. Creatinine Clearance < 15 ml/min
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 use of any 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