Using low dose colchicine to reduce vascular events in patients with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The LEADER-PAD trial is a randomized, double-blind, multicenter trial designed to evaluate the effectiveness of low dose colchicine (0.5 mg daily) compared to a placebo in patients with symptomatic peripheral artery disease (PAD). The study aims to determine if this anti-inflammatory therapy can reduce major adverse cardiovascular and limb events, including myocardial infarction, stroke, and cardiovascular deaths. A total of 6,150 participants will be enrolled, and the primary outcome will focus on composite events related to cardiovascular and limb health. The trial includes an active run-in period to ensure participant adherence and proper assessment of outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting
• University of Florida - Gainesville
  Gainesville, Florida, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Boston Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Michigan Health
  Ann Arbor, Michigan, United States Recruiting

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Noel C Chan, MD — Population Health Research Institute, Hamilton, Ontario, Canada
• Study coordinator: Noel C Chan, MD
• Email: Noel.Chan@TAARI.CA
• Phone: 905-521-2100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.