Not recruiting

Study on Genotype-Guided Treatment with Carbasalate Calcium, Telmisartan, and Rivaroxaban for Patients with Peripheral Arterial Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying treatments for Peripheral Arterial Disease (PAD), a condition where the blood vessels in the legs are narrowed, reducing blood flow and causing symptoms like pain or cramping. The study is comparing a new approach to treatment that uses genetic information to guide therapy, against the standard treatment with Clopidogrel, a medication that helps prevent blood clots. The new approach involves using different medications, including Carbasalate Calcium and Rivaroxaban, which are designed to prevent blood clots in different ways.

The purpose of the study is to see if the new, personalized treatment strategy can better reduce the risk of serious health problems related to blood clots, such as heart attacks, strokes, or issues with blood flow to the limbs, compared to the usual treatment. Participants in the study will receive either the standard treatment or the new treatment based on their genetic makeup, and their health will be monitored over a period of time to track any major health events.

The study will last for up to 36 months, during which participants will take their assigned medication and have regular check-ups to monitor their health. The main goal is to determine if the new treatment approach can lower the chances of serious complications from PAD, including major cardiovascular events, limb problems, or death, compared to the conventional use of Clopidogrel.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, you will be enrolled as a participant. This involves confirming your eligibility based on criteria such as being over 16 years old, having a specific ankle-brachial index, and experiencing symptoms related to peripheral arterial disease.
Step 2
Initial assessment
An initial assessment will be conducted to gather baseline information about your health status. This may include physical examinations and reviewing your medical history.
Step 3
Medication administration
You will be assigned to receive either a genotype-guided antithrombotic treatment or conventional clopidogrel therapy. The medication will be taken orally. If you are in the clopidogrel group, you will take 75 mg once daily.
Step 4
Regular follow-up visits
Throughout the trial, you will attend regular follow-up visits. These visits are important for monitoring your health and the effects of the treatment. The frequency of these visits will be determined by the study protocol.
Step 5
Monitoring and reporting
You will be asked to report any side effects or changes in your health. This information helps in assessing the safety and effectiveness of the treatment.
Step 6
Final assessment
At the end of the study period, a final assessment will be conducted. This will include evaluating the occurrence of any adverse clinical events related to arterial thrombosis, such as heart attacks or strokes.
Step 7
Completion
Upon completion of the trial, you will receive information about the study results and any further steps if necessary.

Who can join the trial?

5 criteria

Must be older than 16 years.
Need to take a medication called clopidogrel at a dose of 75mg once a day. This medication helps prevent blood clots.
Have an ankle-brachial index of less than 0.9 or a toe-brachial index of less than 0.5. These are tests that measure blood flow in your legs.
Currently have or have had symptoms due to poor blood flow in one or both lower legs. Symptoms can include pain when walking, pain at rest, or tissue damage (Rutherford category 1-6).
Have consulted a vascular surgeon for diagnosis, treatment, or follow-up of Peripheral Arterial Disease (PAD). A vascular surgeon is a doctor who specializes in blood vessel conditions.

Who cannot join the trial?

6 criteria

Patients with a history of **myocardial infarction** (heart attack) cannot participate.
Patients who have had a **stroke** (a sudden interruption in the blood supply to the brain) are excluded.
Patients with a history of **transient ischemic attack** (a temporary period of symptoms similar to those of a stroke) are not eligible.
Patients who have experienced **acute or chronic limb ischemia** (reduced blood flow to the limbs) are not allowed to join the study.
Patients who have undergone **peripheral vascular intervention** (procedures to treat blood vessel diseases outside the heart and brain) including **amputation** are excluded.
Patients who are at risk of **death** from any cause are not eligible.

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Verified sites

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

Responsive
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Gelre Hospitals
Zutphen, The Netherlands
Verified
Maxima Medisch Centrum
Veldhoven, The Netherlands

Trial locations

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Investigated drugs

Clopidogrel is a medication used to prevent blood clots in people with certain heart or blood vessel conditions. It works by stopping platelets, which are small blood cells, from sticking together and forming clots. In this trial, it is used as a standard treatment for patients with peripheral arterial disease to help reduce the risk of heart attacks, strokes, and other serious problems related to blood clots.

What is already known about the treatment

Clopidogrel – Clopidogrel is a medication taken orally, usually in the form of a tablet, and is used to prevent blood clots in people with certain heart or blood vessel conditions. It is well-established in medical practice and literature as a standard treatment for reducing the risk of heart attacks and strokes. The main therapeutic use of clopidogrel is to prevent major cardiovascular events in patients with peripheral arterial disease (PAD). At the molecular level, clopidogrel works by inhibiting platelets, which are small blood cells that clump together to form clots, thus reducing the risk of clot formation. It belongs to a class of drugs known as antiplatelet agents.

Investigated diseases

Peripheral Arterial Disease – Peripheral Arterial Disease is a condition where the arteries that supply blood to the limbs become narrowed or blocked. This is usually due to a buildup of fatty deposits, known as atherosclerosis, on the artery walls. As the disease progresses, it can lead to reduced blood flow to the limbs, causing symptoms such as leg pain when walking, known as claudication. In more advanced stages, individuals may experience pain at rest, non-healing wounds, or ulcers on the feet or toes. If left untreated, the condition can lead to severe complications, including tissue death and the need for amputation. The progression of the disease can vary, with some individuals experiencing rapid worsening of symptoms, while others may have a more gradual progression.