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Study on Reduced Antiplatelet Therapy with Acetylsalicylic Acid and Clopidogrel for Patients with Coronary Artery Disease After Stent Implantation

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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 patients with Coronary Artery Disease, a condition where the blood vessels supplying the heart become narrowed or blocked. The study is investigating the effects of different antiplatelet medications, which help prevent blood clots. The medications being studied include Acetylsalicylic Acid (commonly known as aspirin), Clopidogrel, Ticagrelor (also known by the code name AZD6140), and Prasugrel. These medications are used to reduce the risk of heart attacks and other heart-related issues by preventing platelets in the blood from sticking together.

The purpose of the study is to evaluate the outcomes of using a reduced antiplatelet therapy after the implantation of an Angiolite stent, a small tube placed in the coronary arteries to keep them open. The study will compare the effects of a standard dual antiplatelet therapy (using two medications) with an abbreviated, or shortened, therapy. Participants will be randomly assigned to receive either the standard or the abbreviated therapy. The study will last for up to 12 months, during which the rate of heart-related complications and bleeding events will be monitored.

Participants will take the medications orally, meaning they will swallow them in pill form. The study aims to determine if the abbreviated therapy is as effective as the standard therapy in preventing heart-related issues while also reducing the risk of bleeding. This research is important for understanding how to best manage treatment for patients with coronary artery disease who have received a stent.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age and the presence of coronary artery disease. Consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the coronary arteries. This includes identifying any stenosis, which is a narrowing of the arteries, that is 50% or more.

  3. Step 3

    Stent implantation

    A stent, either an angiolite or Xience, is implanted in the affected coronary artery to help keep it open. This procedure is necessary for patients with significant artery narrowing.

  4. Step 4

    Medication regimen

    After stent implantation, a dual antiplatelet therapy (DAPT) is initiated. This involves taking two types of medications orally to prevent blood clots.

    The medications include acetylsalicylic acid and either clopidogrel, ticagrelor, or prasugrel. The specific combination and dosage depend on the group assigned within the study.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's health and the effectiveness of the stent and medication.

    The primary focus is on observing any target lesion failure, which includes cardiovascular death, myocardial infarction, or the need for further intervention at the stent site.

  6. Step 6

    Evaluation of outcomes

    At the 1-year mark, the study evaluates the rate of target lesion failure and any clinically relevant bleeding events.

    The outcomes help determine the effectiveness of the abbreviated antiplatelet therapy compared to the standard regimen.

Who can join the trial?

3 criteria

  • Must be between the ages of 18 and 94 years old.
  • Must have one or more narrowed areas in the heart's blood vessels, known as **coronary artery stenosis**, where the narrowing is 50% or more. This can be in a natural heart artery or in a bypass vessel used in previous heart surgery. The blood vessel should be at least 2.00 mm wide. There is no limit on the number of narrowed areas, the number of blood vessels affected, or the length of the narrowed area.
  • Must be able to understand the study details and agree to participate by signing a consent form.

Who cannot join the trial?

8 criteria

  • Patients who have a known allergy or sensitivity to the materials used in the stents.
  • Patients who are unable to take medications that prevent blood clots, known as antiplatelet therapy.
  • Patients with a history of bleeding disorders, which means they bleed more easily than normal.
  • Patients who have had a heart attack or stroke within the last month.
  • Patients with severe liver or kidney disease, which affects how the body processes medications.
  • Patients who are pregnant or breastfeeding, as the effects on the baby are not known.
  • Patients who are participating in another clinical trial, as this could affect the results.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • Angiolite Stent

    is a medical device used in the trial to help keep blood vessels open in patients with certain heart conditions. It is being tested to see if it is as effective as another type of stent in preventing complications like blockages in the blood vessels.

  • Xience Stent

    is another type of stent used in the trial. It serves a similar purpose as the Angiolite Stent, helping to keep blood vessels open. The trial aims to compare its effectiveness with the Angiolite Stent in preventing issues such as blockages.

  • Dual Antiplatelet Therapy (DAPT)

    is a treatment involving two medications that help prevent blood clots. This therapy is used in patients who have had stents placed in their blood vessels. The trial is comparing the standard duration of this therapy with a shorter, abbreviated version to see which is more effective in reducing bleeding risks while still preventing clots.

What is already known about the treatment

  • Angiolite Stent

    The Angiolite Stent is a medical device used in the treatment of coronary artery disease. It is administered through a minimally invasive procedure where the stent is placed in the coronary arteries to keep them open and ensure proper blood flow. Currently, it is being evaluated in clinical trials to compare its effectiveness and safety against other stents, such as the Xience stent family. The main therapeutic indication is to prevent artery blockage in patients with coronary artery disease. The stent works by providing structural support to the artery and may release medication to prevent further blockage. It falls under the pharmacological classification of drug-eluting stents.

  • Xience Stent Family

    The Xience Stent Family consists of drug-eluting stents used to treat coronary artery disease. These stents are inserted into the coronary arteries via a catheter to maintain open blood vessels and improve blood flow. They are well-established in medical practice and literature, with ongoing studies comparing their performance to newer stents like the Angiolite. The primary therapeutic use is to prevent the re-narrowing of arteries after they have been cleared of blockages. The stents release medication that helps prevent the growth of scar tissue in the artery lining. They are classified as drug-eluting stents in pharmacology.

Investigated diseases

Coronary Artery Disease – This condition occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased, often due to the buildup of cholesterol and other substances, known as plaque, on the artery walls. Over time, this plaque can harden or rupture, leading to narrowed or blocked arteries, which reduces blood flow to the heart. As the disease progresses, it can cause chest pain, shortness of breath, or other symptoms, especially during physical activity or stress. If a plaque ruptures, it can lead to a heart attack, which is a sudden blockage of blood flow to the heart muscle. The progression of coronary artery disease can vary, with some individuals experiencing symptoms early on, while others may not notice any signs until a significant blockage occurs. Regular monitoring and lifestyle changes can help manage the condition and slow its progression.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507015-35-00Estimated enrolment2 312 patientsSponsorIvascular S.L.

sourced from the EU Clinical Trials Register and site verification

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