Status:
RECRUITING
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Lead Sponsor:
Population Health Research Institute
Conditions:
Peripheral Arterial Disease
Atherosclerosis of Extremities
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The LEADER-PAD trial is a randomized, double blind, multicenter trial with an active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with symptomatic peripheral arte...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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%.
- \* 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
- Written or verbal informed consent from the patient
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
6150 Patients enrolled
Trial Details
Trial ID
NCT04774159
Start Date
May 6 2021
End Date
December 1 2029
Last Update
May 29 2025
Active Locations (14)
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1
University of Calgary, Peter Lougheed Centre Vascular Clinic
Calgary, Alberta, Canada
2
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, Canada
3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
4
London Health Sciences Centre
London, Ontario, Canada