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.

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What is this study about?

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.

Who Can Join the Study?

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).
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 Study?

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 100×109/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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Prive Dijon Bourgogne	Dijon	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hopital Beaujon	Clichy	France
Societe De Gestion Clinique Sainte Clotilde	St Denis	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Clxybn Howixxinuwx Rkbuedsy Dzdozxvvjadzli	Angers	France
Ccvqtrhy Gkloabst	Annecy	France
Cativo Hudvobzzjgo Ee Uditcsnpfjkiv Dn Lxuzlyr	Limoges	France
Autedywdsu Pqxbzute Hhtocrld Df Mbvydldde	Marseille	France
Bcxvzafk Uompmjpeqb Hjrnnmyz Cxyqcu	Besançon	France
Cqqt Dj Nabxi	Vandoeuvre Les Nancy	France
Gxsnrt Hfwvfstpjaj Uxwgcogrqamvq Pflqa Pdvlagdzeio Ed Nyawzaxkbikp	Paris	France
Iqetevsg du Cvjgoxnixtuv Hujjbqplqsj Uckuhjsljjbma dw Snbbh Efpfsqm (dqvejnb	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	05.01.2026

Trial locations

Investigated drugs:

Clopidogrel

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.

Investigated diseases:

Peripheral artery angioplasty

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.

Trial ID:

2025-524297-42-00

Protocol code:

PHRC-23-0035

Trial Phase:

Therapeutic confirmatory (Phase III)

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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.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?