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Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk: A randomized trial- LEADER PAD
EU CTIS ID: 2024-512091-35-01
What this study is testing
The overall objective of this research program is to examine the efficacy and safety of colchicine 0.5 mg/daily in reducing the incidence of cardiovascular death, myocardial infarction, stroke or severe limb ischemia requiring an intervention including major vascular amputation in PAD patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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; or d. Leg or foot amputation for arterial vascular indications
- Written informed consent from the patient
You likely can't join if
- Contraindication to colchicine (including hypersensitivity to the active substance or to any of the excipients)
- Patients with blood dyscrasias
- Patients with severe heart failure (NYHA class IV)
- Patients with severe gastrointestinal insufficiency
- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening, or within the 5 half-lives of the study drug, whichever is longer
- Long term requirement for colchicine for another clinical indication
See the full eligibility 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; or d. Leg or foot amputation for arterial vascular indications
- Written informed consent from the patient
- Contraindication to colchicine (including hypersensitivity to the active substance or to any of the excipients)
- Patients with blood dyscrasias
- Patients with severe heart failure (NYHA class IV)
- Patients with severe gastrointestinal insufficiency
- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening, or within the 5 half-lives of the study drug, whichever is longer
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Mexico
- India
- Brazil
- United States
- Argentina
- United Kingdom
- Australia
- Turkey
- Canada
- Ecuador
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Mexico; India; Brazil; United States; Argentina and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.