Recruiting

A study comparing one month versus one year of aspirin and clopidogrel treatment in patients with chronic limb-threatening ischemia after below-the-knee vascular therapy.

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Chronic Limb Threatening Ischemia, a severe condition where blood flow to the legs is so poor that it causes pain or tissue damage. The research aims to determine the best length of time to use dual anti-platelet therapy, which is a combination of two medications used to prevent blood clots, following a procedure to improve blood flow in the lower legs. All participants in the study will also take rivaroxaban as part of their standard care.

Participants will be assigned to receive different treatment plans. One group will take aspirin and clopidogrel for one year, while another group will take these same medications for only one month. Some participants may receive a placebo. The study follows these individuals over a period of time to monitor health outcomes related to the leg and overall survival.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of medication regimen
You will begin taking rivaroxaban at a dose of 2.5 mg, taken two times per day. this medication is provided as a standard part of the care for your condition.
You will be assigned to one of two groups to receive dual anti-platelet therapy, which is a combination of two medicines to prevent blood clots. one part of this therapy is aspirin (taken at a dose of 75-160 mg per day).
The second part of the therapy involves either clopidogrel (75 mg per day) or a placebo, which is a pill with no active medicine, to ensure the study remains double-blind. being double-blind means neither you nor the medical staff will know which specific pill is being taken.
Step 2
Medication duration
Depending on the group assigned, the dual anti-platelet therapy will last for either one month or one year.
Throughout the 12-month study period, your health and the effectiveness of the treatment will be monitored.

Who can join the trial?

10 criteria

You must be 18 years of age or older.
You must be hospitalized and have Chronic Limb-Threatening Ischemia (CLTI), which is a severe form of blocked blood flow to the legs that has lasted for more than 2 weeks.
Your CLTI must be classified as Rutherford category 4 (having pain even while resting) or category 5 (having minor tissue loss, such as an ulcer that will not heal or a small area of dead tissue known as gangrene).
check
You must have one or more abnormal blood pressure readings in the legs, which are measured by:
- Ankle-brachial index (ABI) being less than 0.4, which is a comparison of the blood pressure in your ankle to the blood pressure in your arm.
- The highest ankle pressure being less than 50 mm Hg.
- The toe pressure being less than 30 mm Hg.
- You must have had a successful endovascular revascularization within the last 7 days. This is a procedure where doctors use small tubes or wires to open blocked arteries in the legs, specifically focusing on the arteries below the knee. This may involve angioplasty (inflating a small balloon to widen the artery) or stenting (placing a small mesh tube to keep the artery open).
- You must be covered by the French Health Insurance system.
- You must be able to understand and sign a written consent form, which is a document that explains the study to you before you agree to join.
- Women who are able to become pregnant must have a negative pregnancy test and use effective contraception (methods to prevent pregnancy).

Who cannot join the trial?

21 criteria

Having Peripheral Artery Disease (PAD) that falls into certain categories, including Rutherford category 6, which is a way to grade the severity of blood flow problems, specifically when there are severe ulcers (open sores) or gangrene (tissue death) that spread beyond the toes.
Requiring dialysis or renal replacement therapy, which are treatments used when the kidneys can no longer work properly, or having renal impairment (kidney damage) where the estimated glomerular filtration rate (eGFR), a measure of how well the kidneys filter blood, is too low.
Having had acute coronary syndrome (ACS), which refers to a sudden decrease in blood flow to the heart, within 30 days before starting the study.
Experiencing a major trauma or serious accident within 30 days before joining the study.
Having a medical history of intracranial hemorrhage (bleeding inside the skull), a stroke (interruption of blood supply to the brain), or a transient ischemic attack (TIA), which is often called a "mini-stroke."
Having an active malignancy, which is another word for cancer, though local skin cancers like basal cell carcinoma or squamous cell carcinoma are allowed.
Having diabetes that is not well managed.
Having hypertension (high blood pressure) that is severe and not well controlled.
Participating in another medical study involving a drug or a device within the last 30 days.
Being a close relative, employee, or student of the people running the study site.
Being unable to complete the follow-up appointments or unable to follow the study rules.
Having acute limb ischemia, which is a sudden loss of blood flow to an arm or leg, within one month before the procedure.
Being in a situation where your freedom is restricted, such as being in prison.
Being under tutorship, curatorship, or legal protection.
Being pregnant or currently breastfeeding.
Having a platelet count lower than 100x109/L; platelets are the cells in your blood that help it clot.
Needing dual antiplatelet therapy, which is the use of two medicines to prevent blood clots, for a reason other than Peripheral Artery Disease (PAD).
Needing to take an anticoagulant, which is a blood-thinning medicine, such as VKA or DOAC, other than the specific low dose of rivaroxaban allowed in this study.
Having a known allergy or sensitivity to aspirin or clopidogrel.
Having a history of or active significant bleeding within the last 6 months, including issues like gastrointestinal ulceration (sores in the stomach or intestines), high-risk cancers, brain or spinal injuries, esophageal varices (swollen veins in the throat), or blood vessel abnormalities in the brain or spine.
Having any hepatic disease (liver disease) that causes coagulopathy, which is a condition where the blood cannot clot normally.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Besancon University Hospital Center
Besançon, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Clopidogrel
is a medication used to prevent blood cells called platelets from sticking together and forming clots in the blood vessels.
Aspirin
is a medicine that helps prevent blood clots from forming, which can help keep blood flowing more easily through the arteries.
Rivaroxaban
is a type of medicine used to thin the blood and reduce the risk of blood clots forming in the body.

Clopidogrel

What is already known about the treatment

Clopidogrel
This medication is taken by mouth in the form of a film-coated tablet. It is a well-established medicine used to prevent blood clots from forming in the arteries, which helps reduce the risk of heart attacks and strokes. It works by blocking a specific part of the tiny blood cells called platelets, preventing them from sticking together to form dangerous clots. It belongs to a class of drugs known as antiplatelet agents.
Lactose monohydrate
This substance is used as a placebo in this study and is typically administered in the same way as the test medication. It is an inactive ingredient that does not have any medicinal effect or therapeutic purpose on its own. In clinical trials, it is used to create a pill that looks and feels exactly like the real medicine to ensure the study remains fair and unbiased. It is classified as an inactive filler or excipient.

Investigated diseases

Chronic Limb-Threatening Ischemia - This condition occurs when blood flow to the legs is severely restricted due to narrowed or blocked arteries. It is an advanced stage of peripheral artery disease where the lack of oxygenated blood causes significant tissue damage. The disease typically progresses from intermittent pain during activity to constant pain even while resting. Over time, the lack of circulation can lead to the formation of open sores or ulcers that do not heal. If the blood flow is not restored, the affected tissue may undergo necrosis, which is the death of body tissue.