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Study on Dual Antiplatelet Therapy Duration for Patients with Chronic Coronary Artery Blockage Using Clopidogrel and D,L-Lysine Acetylsalicylate

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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 a condition known as chronically occluded coronary artery, which is a blockage in the heart's blood vessels that has been present for a long time. The study is investigating the effects of two different durations of a treatment called dual antiplatelet therapy (DAPT). This therapy involves using two medications to prevent blood clots. The medications being studied are Clopidogrel, a film-coated tablet, and Kardegic, an oral solution containing D,L-Lysine Acetylsalicylate, which is a form of aspirin.

The purpose of the study is to compare the effectiveness of a short duration of DAPT, lasting 1 month, with the usual longer duration of 6 to 12 months. The study aims to see how these different durations affect the occurrence of adverse events, such as bleeding or ischemic events, which are problems caused by reduced blood flow, over a period of 12 months. Patients who have successfully undergone a procedure called coronary angioplasty for their blocked artery will be part of this study. This procedure involves using a small balloon to open up the blocked artery.

Participants in the study will be randomly assigned to receive either the short or long duration of DAPT. They will be monitored over the course of a year to track any adverse events, such as bleeding or heart-related issues, and to assess their overall health and quality of life. The study will also evaluate the costs associated with each treatment duration and how well patients adhere to their medication regimen. The goal is to determine which treatment duration is more beneficial for patients in terms of safety and effectiveness.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after successful coronary stent implantation for a chronically blocked artery.

    Eligibility includes being over 18 years old, able to take long-term aspirin, and requiring dual antiplatelet therapy.

    Informed consent must be signed.

  2. Step 2

    Medication administration

    The study involves taking two medications: clopidogrel and KARDEGIC 75 mg.

    Both medications are taken orally as an oral solution.

    The duration of the dual antiplatelet therapy (DAPT) is either 1 month or 6 to 12 months, depending on the group assigned.

  3. Step 3

    Follow-up and monitoring

    The follow-up period lasts for 12 months.

    Monitoring includes checking for any adverse events such as bleeding or ischemic events.

    Regular assessments occur at 1, 6, and 12 months to ensure compliance with the medication regimen.

  4. Step 4

    Evaluation of outcomes

    The primary goal is to evaluate the occurrence of adverse clinical events over 12 months.

    Secondary outcomes include the time to any bleeding event, all-cause death, and major adverse ischemic events.

    The study also assesses the total costs and quality-adjusted life years for each treatment group over the one-year period.

Who can join the trial?

6 criteria

  • Patients who have had a successful procedure to place a small tube called a stent in a blocked heart artery.
  • Patients must be able to take aspirin for a long time. Aspirin is a medicine that helps prevent blood clots.
  • Patients need to take two types of medicine that prevent blood clots, known as dual antiplatelet therapy.
  • Patients must be part of the Social Security system.
  • Patients must sign a form that shows they understand the study and agree to participate, known as informed consent.
  • Patients must be older than 18 years.

Who cannot join the trial?

3 criteria

  • Patients who have a **chronically occluded coronary artery** cannot participate. This means that one of the arteries in the heart is completely blocked for a long time.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection or care.
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Investigated drugs

  • Aspirin

    is a medication used to reduce pain, fever, or inflammation. In this trial, it is used as part of dual antiplatelet therapy to help prevent blood clots in patients who have undergone coronary angioplasty for a chronically occluded coronary artery.

  • Clopidogrel

    is an antiplatelet medication that helps prevent blood clots by making the blood less sticky. It is used in combination with aspirin in this trial to reduce the risk of adverse clinical events, such as bleeding or ischemic events, after coronary angioplasty.

What is already known about the treatment

Clopidogrel – This medication is administered orally in tablet form and is commonly used in the treatment of patients who have undergone procedures like coronary angioplasty, particularly for chronically occluded coronary arteries. It is well-established in medical literature as an antiplatelet agent, helping to prevent blood clots. Clopidogrel works by inhibiting a specific receptor on platelets, which reduces their ability to clump together. It is classified pharmacologically as a platelet aggregation inhibitor.

Investigated diseases

Chronically Occluded Coronary Artery – This condition occurs when a coronary artery is completely blocked for an extended period, typically over three months. The blockage is usually due to a buildup of fatty deposits, known as plaque, which restricts blood flow to the heart muscle. Over time, this can lead to the development of collateral circulation, where smaller blood vessels form to bypass the blockage. However, these vessels may not provide sufficient blood flow, leading to symptoms such as chest pain or discomfort, especially during physical exertion. The condition can progress to cause more severe symptoms if the collateral circulation is inadequate. It is often diagnosed in patients undergoing evaluation for coronary artery disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508148-23-01Protocol codeEtude DAPT-CTOEstimated enrolment660 patientsSponsorAssistance Publique Hopitaux De Marseille

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).