Overview

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

Status:
Recruiting

Trial end date:
2023-09-01

Target enrollment:
0

Participant gender:
All

Summary

The vanguard phase of the Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate the feasibility of conducting a full randomized trial to determine if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Population Health Research Institute

Treatments:

Colchicine

Criteria

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