RecruitingPhase 3

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

United States6,150 participantsStarted 2021-05-06

Plain-language 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 events in patients with symptomatic peripheral artery disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age \> 18 years
✓. Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:
✓. 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

What they're measuring

Major adverse cardiovascular and limb events (MACE or MALE)

Timeframe: 3-5 years

Trial details

NCT IDNCT04774159

SponsorPopulation Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Noel C Chan, MD

905-521-2100 Noel.Chan@TAARI.CA

View on ClinicalTrials.gov More Peripheral Arterial Disease trials