Intermittent claudication Trials in Disease

Study on Low-Dose Colchicine for Patients with Peripheral Artery Disease to Reduce Cardiovascular Risks

This clinical trial is investigating whether a low-dose form of colchicine, a medication typically used to reduce inflammation, can help protect patients with peripheral artery disease from serious cardiovascular complications. Peripheral artery disease occurs when blood vessels outside the heart and brain become narrowed, often leading to reduced blood flow to the limbs and causing symptoms like leg pain during walking.

Main inclusion criteria:

• Must be over 18 years old
• Must have symptoms of peripheral arterial disease in the legs with at least one of the following:
  • Experience intermittent claudication with an ankle/arm blood pressure ratio of 0.90 or less, or have an artery narrowed by 50% or more, plus have multiple areas affected by atherosclerosis, diabetes, heart failure, or chronic kidney disease
  • Experience rest pain, tissue death, or gangrene with an ankle/arm blood pressure ratio of 0.90 or less
  • Have undergone a procedure to restore blood flow, such as bypass surgery
  • Have had a leg or foot amputation due to blood flow problems
• Must provide written informed consent to participate

Main exclusion criteria:

• Patients who do not have peripheral arterial disease
• Patients who are not within the specified age range
• Patients who belong to a vulnerable population requiring special protection or care

Focus and goals:

The trial aims to examine how effective and safe colchicine is in lowering the chances of serious events like heart attacks, strokes, or severe issues with blood flow to the limbs that might require medical procedures or amputation. Participants will take either colchicine tablets or a placebo daily and will be monitored throughout the study period. Researchers will track various health outcomes, including heart-related events, hospitalizations, and the need for procedures to improve blood flow. The ultimate goal is to determine whether colchicine can improve quality of life and reduce the risk of serious complications for people living with this condition.

Investigational drug:

The study uses Colchicine Tiofarma 500 microgram Tablets, which are taken orally once daily. Colchicine works by reducing inflammation in the body, which may help prevent vascular complications. It is being investigated for its potential to reduce cardiovascular events such as heart attacks, strokes, and severe limb problems in patients with peripheral artery disease.