AuthorisedTherapeutic confirmatory (Phase III)Interventional

Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia after Distal Revascularization: a randomized, double-blind trial PALADIN [PeripherAL Arterial DIsease Network] -DAPTCLTI

This study, called PALADIN-DAPTCLTI, is looking into the best amount of time to take a blood-thinning medicine called clopidogrel after surgery for severe leg circulation problems. This condition, called Chronic Limb Threatening Ischemia (CLTI), means blood flow to the legs is very poor. Researchers want to find out if taking clopidogrel for a certain period helps people avoid losing their leg (amputation) or dying within 12 months after surgery. They will also look at other important things like how often people need more surgery, if they have heart attacks or strokes, how their quality of life changes, and if they experience any serious bleeding. This study is happening all over the world and aims to find the safest and most effective treatment plan.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fondation Hopital Saint Joseph

Enrolment target

614

Start

05 Mar 2026

CLTI defined as Rutherford category 4 or 5

What is this study about?

This study is about a serious condition called Chronic Limb Threatening Ischemia (CLTI), where blood flow to the legs is very poor. This can cause severe pain and wounds that don't heal, and in some cases, might lead to needing an amputation. To help with this, doctors often perform surgery to improve blood flow. After this surgery, patients are usually given a blood-thinning medicine, like clopidogrel, to help prevent clots.

What doctors don't know for sure is the exact right length of time to keep taking this blood-thinning medicine. Taking it for too short a time might mean the benefits wear off, while taking it for too long could increase the risk of side effects, like bleeding. This study, called PALADIN-DAPTCLTI, aims to find the best balance.

By comparing different lengths of time for taking clopidogrel, the researchers hope to find out what helps people live longer and avoid needing another amputation, while also having a good quality of life and as few complications as possible, like serious bleeding, heart attacks, or strokes. This research is important because it could help doctors create better treatment plans for people with CLTI, improving their health and well-being.

Key takeaways

This study evaluates the best duration for blood-thinning medicine after leg surgery.
It aims to reduce amputation and death risks for people with severe circulation problems.
Participants will take clopidogrel or an inactive tablet for different lengths of time.
Your health will be closely monitored for 12 months.
The study also looks at quality of life, heart problems, and bleeding.
Results could help improve future treatments for CLTI patients.

Who may be eligible?

To join this study, you would generally need to be an adult, 18 years or older, and have been diagnosed with a severe form of poor circulation in your legs, known as Chronic Limb Threatening Ischemia (CLTI). This usually means you have severe pain in your foot or toes, or non-healing sores or gangrene in your leg or foot.

Crucially, you must have recently had a specific type of surgery to improve the blood flow in your leg. The study may also require you to meet other specific health criteria, as determined by the study doctors, to make sure it's safe and appropriate for you to participate.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with severe leg circulation problems (CLTI)?
Have you recently undergone surgery to improve blood flow in your leg?
Are you able to attend regular follow-up appointments for a year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would be randomly put into one of two groups, like flipping a coin. You wouldn't know which group you are in, and neither would your study doctor. Both groups would receive the study medicine, clopidogrel, in tablet form, along with another inactive substance (a placebo that looks like the real medicine) at different times. This helps researchers fairly compare the different treatment lengths.

Taking part would involve regular visits to the clinic, where you would have physical examinations, blood tests, and answer questions about your health and how you feel. These checks would happen consistently over a period of 12 months (one year). The study will carefully monitor your health for complications like amputation, death, heart problems, strokes, and bleeding.

Potential risks and benefits

Taking part might offer the potential benefit of closer monitoring of your health and contributing to important medical knowledge that could help future patients. However, there are potential risks, mainly related to the blood-thinning medicine, which can increase the chance of bleeding, from minor bruising to more serious bleeding internally. While the study tries to find the best balance, your treatment may not be better than standard care, and could potentially be worse. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is CLTI?

CLTI stands for Chronic Limb Threatening Ischemia. It's a severe condition where blood flow to your legs is very poor, which can cause pain, wounds, and sometimes lead to amputation.

What is clopidogrel?

Clopidogrel is a medicine that helps prevent blood clots. It's often called a 'blood thinner' and helps keep blood flowing smoothly, especially after procedures like leg surgery.

Why is this study 'double-blind'?

Double-blind means neither you nor your study doctor will know which treatment group you're in. This helps ensure the results are fair and not influenced by anyone's expectations.

How long will I be in the study?

The main part of the study will involve monitoring your health for 12 months (one year) after you start the treatment.

Will I have to pay to be in the study?

Generally, you won't have to pay for the study medicine or related study appointments. Travel costs may or may not be covered, so it's good to ask the study team.