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

ConditionsPeripheral Arterial Disease Atherosclerosis of Extremities Inflammation

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorPopulation Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Written or verbal informed consent from the patient

Disqualifiers

Contraindication to colchicine

Long term requirement for colchicine for another clinical indication

Active diarrhoea

eGFR < 30 mL/min/1.73 m2

Trial design

Design model

Parallel

Treatments tested in this trial

Colchicine 0.5 MG Oral Tablet
Drug
Colchicine 0.5 mg tablet daily Active drug and placebo are of the same appearance and are indistinguishable. All investigators, study personnel and patients will be blinded to drug treatment assignment. Trial treatment supplies must be stored in a secure, limited-access location under the storage conditions specified on the IP supply label.
Colchicine-Placebo
Drug
Colchicine-Placebo tablet

Treatment groups

6,150 Participants

are divided into 2 treatment groups

Group A: ColchicineActive comparator 1 intervention

Group B: Colchicine-PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Major adverse cardiovascular and limb events (MACE or MALE)

This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher)

Time frame

3-5 years

Secondary outcomes

Extended MALE

This composite outcome includes major adverse limb events (MALE) as well as revascularization for new or worsening claudication of new stenosis or occlusion detected on screening after a previous intervention

Time frame

3-5 years

Cardiovascular death

Death will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause will be classified as cardiovascular. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular.

Time frame

3-5 years

Myocardial infarction

Acute myocardial infarction (AMI) requires evidence of acute myocardial injury with clinical evidence of acute myocardial ischemia

Time frame

3-5 years

Stroke

Stroke requires the presence of acute focal or global\* neurological dysfunction caused by brain or retinal vascular injury due to primary hemorrhage or infarction.

Time frame

3-5 years

Other outcomes

Occurrence of gastrointestinal toxicity (such as diarrhoea, nausea or vomiting) that results in study drug discontinuation

Safety outcome

Time frame

3-5 years

Muscle pain (myalgia or myositis), that results in study drug discontinuation

Safety outcome

Time frame

3-5 years

Infection (e.g., pneumonia) leading to hospitalization

Safety outcome

Time frame

3-5 years

New diagnosis of cancer

Safety outcome

Time frame

3-5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Source ClinicalTrials.gov

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