Purpose of this Study
We are doing this study to find out if a small dose (0.5 mg) of a drug called colchicine (the study drug) is beneficial for people with peripheral artery disease (PAD). We want to know if it has the potential to lower the risk of heart attack, stroke, and corrective leg surgeries for people who have PAD. The study drug is FDA-approved for the treatment of some inflammatory conditions (e.g., gout), but it is not approved for the treatment of PAD.
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed with symptomatic, atherosclerotic PAD in the leg that has at least one of the following features:
- Intermittent claudication with ankle/arm blood pressure ratio* (ABI) or 0.90 or lower, or artery stenosis of at least 50%
- 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)
- Revascularization that is 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
- Leg or foot amputation for arterial vascular indications
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to either take the study drug or a placebo (inactive substance that has no drug in it). You will take the study drug/placebo by mouth every day for approximately 3 years.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk: A randomized trial
Principal Investigator
Jennifer
Rymer
Protocol Number
PRO00118192
NCT ID
NCT04774159
Phase
III
Enrollment Status
Pending Open to Enrollment