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Study of acetylsalicylic acid and clopidogrel treatment after left atrial appendage closure in patients with atrial fibrillation and chronic kidney 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 focuses on patients with Atrial Fibrillation who have undergone a procedure called Left Atrial Appendage Closure and are receiving kidney dialysis treatment. The study aims to find the best blood-thinning medication strategy after this heart procedure to prevent blood clots while minimizing bleeding risks.

The study will test two blood-thinning medications: acetylsalicylic acid (commonly known as aspirin) and clopidogrel. These medications help prevent blood clots from forming. Both medications are taken as tablets by mouth. The study will compare different durations of taking these medications, including using both medications together for different periods versus using just one medication.

Patients who participate will be monitored for several important health outcomes, including stroke, blood clots, bleeding events, and heart-related complications. The study will also look at brain function using MRI scans and cognitive tests to ensure the treatment approach is safe and effective. The medications will be given in specific doses - 75 mg daily for each medication - and patients will be followed for several months to evaluate the safety and effectiveness of different medication combinations.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial procedure

    You will undergo a left atrial appendage closure procedure (a heart procedure to prevent blood clots)

    After the procedure, you will receive two medications: acetylsalicylic acid (aspirin) and clopidogrel, both taken by mouth

  2. Step 2

    First month after procedure

    You will continue taking both medications (aspirin and clopidogrel) for the first 30 days

    Regular dialysis treatment will continue as usual

    Medical staff will monitor your health status

  3. Step 3

    One-month assessment

    You will be assigned to one of two treatment groups

    Group 1: Continue taking only one medication until 6 months after the procedure

    Group 2: Continue taking both medications until 6 months after the procedure

  4. Step 4

    Six-month period

    Regular health assessments will be conducted

    Brain imaging (MRI) will be performed to check for any changes

    Cognitive function testing will be conducted using a special examination

    Your dialysis access site will be monitored

  5. Step 5

    After six months

    A decision will be made about continuing or stopping medication

    Regular follow-up visits will continue to monitor your health

    The study will track your progress for several years to ensure safety and effectiveness

Who can join the trial?

7 criteria

  • Patient must have had a successful closure of the left atrial appendage (a small pouch in the heart) using either an Amplatzer or WATCHMAN device within the past 37 days
  • Patient must have end-stage kidney disease and be receiving regular treatment through either:
    • Hemodialysis (blood cleaning through a machine)
    • Peritoneal dialysis (cleaning blood through the belly lining)
    • Patient must be 18 years of age or older
    • Patient must be willing to follow all study requirements, including:
      • Following the assigned treatment plan
      • Attending all follow-up visits
      • Patient must be willing to provide written informed consent to participate in the study

Who cannot join the trial?

16 criteria

  • Age below 18 years or above 65 years
  • Presence of blood clots in the heart chambers
  • Recent major bleeding within the last 30 days
  • Active stomach or intestinal ulcers
  • Severe allergic reaction to blood-thinning medications
  • Inability to take antiplatelet medications (medications that prevent blood clots)
  • Planned major surgery within the next 6 months
  • Life expectancy less than 1 year
  • Previous stroke within the last 3 months
  • Severe heart valve disease
  • Active cancer requiring treatment
  • Pregnancy or planning to become pregnant
  • Severe liver disease
  • Uncontrolled high blood pressure
  • Current participation in another clinical trial
  • Mental conditions that prevent understanding of study requirements
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Investigated drugs

  • Dual Antiplatelet Therapy (DAPT)

    This is a combination of two medications that help prevent blood clots. It's commonly used after certain heart procedures to reduce the risk of complications. The therapy works by making blood platelets less sticky and less likely to form clots.

  • Single Antiplatelet Therapy (SAPT)

    This is a single medication that helps prevent blood clots. It's a simpler form of blood-thinning treatment compared to DAPT, usually involving one medication that prevents platelets from sticking together. This therapy is often used for long-term prevention of blood clots after the initial treatment period.

  • Left Atrial Appendage Closure (LAAC)

    While not a medication, this is a medical procedure that involves placing a device to close off a small pouch in the heart called the left atrial appendage. This procedure is performed to reduce the risk of blood clots forming in this area and potentially causing a stroke, particularly in patients who have kidney disease requiring dialysis.

What is already known about the treatment

Based on the provided trial data about antiplatelet therapy in patients with atrial fibrillation and chronic kidney disease, here are the relevant medications: DAPT (Dual Antiplatelet Therapy) - A combination therapy typically consisting of two antiplatelet medications used together to prevent blood clots in patients with cardiovascular conditions. This treatment is administered orally in tablet form and represents the standard of care following certain cardiac procedures. DAPT works by preventing platelets from sticking together through two different molecular pathways, significantly reducing the risk of blood clot formation. It belongs to the pharmacological class of platelet aggregation inhibitors and is commonly prescribed for specific durations following cardiac interventions. SAPT (Single Antiplatelet Therapy) - A treatment approach using a single antiplatelet medication, typically taken orally once daily, to prevent blood clot formation while potentially reducing bleeding risks compared to dual therapy. SAPT functions by blocking one specific pathway of platelet activation and aggregation, providing necessary antithrombotic protection while potentially offering a better safety profile for long-term use. This therapy belongs to the antiplatelet class of medications and is often used as a maintenance treatment following an initial period of more intensive antiplatelet therapy.

Investigated diseases

Atrial Fibrillation – A heart rhythm disorder where the upper chambers of the heart beat irregularly and often rapidly, out of sync with the lower chambers. The condition occurs when electrical signals in the heart become chaotic, causing an irregular heartbeat pattern. This irregular rhythm can allow blood to pool in the heart chambers, which may lead to the formation of blood clots. The condition can be persistent or come and go in episodes. People with atrial fibrillation may experience heart palpitations, shortness of breath, and reduced ability to exercise.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516384-93-00Protocol codeCKD/1458/21Estimated enrolment80 patientsSponsorNarodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

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