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New treatment option for Peripheral Arterial Disease
Official title Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
ClinicalTrials.gov ID: NCT04774159
What this study is testing
What is Colchicine 0.5 MG Oral Tablet?
Colchicine 0.5 MG Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripheral arterial disease.
Also referred to as Colchicine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 ≤...
- Written or verbal informed consent from the patient
You likely can't join if
- 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...
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...
- Written or verbal informed consent from the patient
- 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
- Patients with life expectancy \< 1 year
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Newark, New Jersey, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Raleigh, North Carolina, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Lubbock, Texas, United States
- Norfolk, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Perth, Western Australia, Australia
- Leuven, Belgium
- Blumenau, Santa Catarina, Brazil
+ 43 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Gainesville, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States and 57 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 ClinicalTrials.gov; the study team decides eligibility.