Home › Trials › NCT04774159

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

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized Trial

Phase 3 Interventional Population Health Research Institute · NCT04774159

This study is testing if a low dose of colchicine can help people with peripheral artery disease avoid serious heart and leg problems compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment6150 (estimated)
Ages18 Years and up
SexAll
SponsorPopulation Health Research Institute Academic / other
Locations70 sites (New Haven, Connecticut and 69 other locations)
Trial IDNCT04774159 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years with symptomatic atherosclerotic peripheral artery disease.

Not a fit: Patients without symptomatic peripheral artery disease or those with conditions that do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of serious vascular events in patients with peripheral artery disease.

How similar studies have performed: Previous studies have shown promise in using colchicine for cardiovascular conditions, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

New Haven, Connecticut and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peripheral Arterial DiseaseAtherosclerosis of ExtremitiesInflammationAcute limb ischemiaMyocardial InfarctionStrokeCardiovascular deathMortality
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.