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Safety and pharmacodynamics of cangrelor tetrasodium in paediatric patients with congenital heart disease undergoing percutaneous vascular procedures

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What is this trial about?

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

The study focuses on children from birth to under 18 years who have Congenital Heart Disease, a condition where the heart’s structure is different from normal at birth. During heart‑related procedures that involve inserting a thin tube through a blood vessel, participants will receive an intravenous medication called Cangrelor that works to keep platelets from forming clots while the procedure is performed.

The purpose of the study is to evaluate the safety of the recommended dose of this medication in the pediatric population. Children who need diagnostic or therapeutic percutaneous vascular procedures will be given the drug during the procedure and then observed for several days. Researchers will watch for any bleeding, breathing problems such as wheezing or shortness of breath, changes in kidney function, vital signs like heart rate and blood pressure, and any other side effects that may occur.

After the infusion, participants remain in the hospital for monitoring, and follow‑up checks may be scheduled to ensure recovery and to record any adverse events. The study collects information on how well the medication is tolerated, without using any comparison or placebo, and aims to provide data that could help improve care for children with this heart condition.

The research process

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

  1. Step 1

    Initial visit and consent

    You arrive at the study centre on the day you are scheduled to join the trial. a member of the study team explains the purpose of the research, the procedures that will be performed, and the possible risks. you sign a consent form indicating that you understand and agree to participate.

    Your baseline information is recorded, including age, weight, medical history of congenital heart disease, and any current medications.

  2. Step 2

    Baseline assessments

    A physical examination is performed and vital signs such as heart rate, systolic and diastolic blood pressure are measured.

    Blood samples are taken for laboratory tests that include complete blood count, blood chemistry, and kidney function. a urine sample is also collected for analysis.

  3. Step 3

    Pre‑procedure preparation

    You are scheduled for a diagnostic or therapeutic percutaneous vascular procedure that will be used to manage your congenital heart disease.

    Any required fasting or medication adjustments are explained, and you are instructed to follow them before the procedure.

  4. Step 4

    Administration of <b>cangrelor</b>

    Immediately before the vascular procedure, the study medication cangrelor tetrasodium is prepared as a solution for injection or infusion.

    The dose is calculated based on your body weight in micrograms per kilogram (µg/kg). the medication is given by intravenous infusion, meaning it is delivered directly into a vein through a needle or catheter.

    The infusion is started at the beginning of the procedure and continues continuously for the duration of the procedure. no additional doses are given after the procedure is completed.

  5. Step 5

    Monitoring during infusion

    While the infusion is running, your heart rate, blood pressure, and breathing are checked regularly.

    The study staff observes you for any signs of bleeding, respiratory distress such as wheezing or shortness of breath, and for changes in urine output.

    Additional blood samples may be taken during the procedure to assess laboratory parameters.

  6. Step 6

    Post‑infusion observation

    After the infusion is stopped, you remain under observation for at least 72 hours from the start of the infusion.

    During this period, vital signs continue to be measured, and repeat laboratory tests are performed to monitor blood counts, chemistry, and kidney function.

    The study team records any bleeding events, need for blood product transfusion, new or worsening respiratory symptoms, and any adverse events such as decreased urine output.

  7. Step 7

    Final assessment and discharge

    At the end of the 72‑hour observation period, a final assessment is completed. this includes a physical exam, vital sign check, and final laboratory tests.

    If no safety concerns are identified, you are discharged from the study centre with instructions for any follow‑up that may be required.

Who can join the trial?

5 criteria

  • Age requirement: you must be a boy or girl from birth up to, but not including, 18 years old.
  • Heart condition: you must have been diagnosed with congenital heart disease (a heart problem present at birth). This includes conditions such as patent ductus arteriosus, coarctation of the aorta, atrial septal defect, ventricular septal defect, or valvular stenosis.
  • Planned procedure: you must be expected to have a diagnostic or therapeutic percutaneous vascular procedure. This means a test or treatment done through a small needle or catheter inserted through the skin into a blood vessel.
  • Female participants: you must be either unable to become pregnant (non‑childbearing potential) or, if you could become pregnant, you must be either not sexually active (no birth control needed) or, if sexually active, agree to use a highly effective form of birth control from the time you sign the consent until you leave the study (day 4 or discharge).
  • Male participants: you must be either non‑fertile (no birth control needed), or fertile but without a female partner (no birth control needed), or fertile with a partner who cannot become pregnant (no birth control needed), or fertile with a partner who could become pregnant and agree to use a male condom from the time you sign the consent until you leave the study (day 4 or discharge).

Who cannot join the trial?

5 criteria

  • Being less than 37 weeks old when adjusted for any time spent outside the womb (the corrected age is the age you would be if you had been born at full term); you cannot join if your corrected age is under 37 weeks at the time of screening.
  • Having had bleeding inside the brain (intracerebral bleeding) or a birth defect where blood vessels in the brain are tangled (cerebral arteriovenous malformation), or any previous bleeding that caused neurological problems.
  • Having any stomach, intestinal, or urinary tract bleeding in the two weeks before screening, except for normal menstrual bleeding.
  • Having a platelet count (the number of small blood cells that help clot) lower than 150,000 or higher than 450,000 per microliter of blood at screening.
  • Having a known allergy to the study drug Cangrelor or to any ingredient in the drug.
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Investigated drugs

Kengrexal is an intravenous medication that works as a fast‑acting platelet inhibitor. In this study it is given to children from birth up to 18 years old who are having diagnostic or therapeutic procedures that involve inserting a thin tube (catheter) into their blood vessels to treat congenital heart disease. The drug helps prevent blood clots from forming during the procedure, allowing doctors to safely perform the necessary vascular work. The trial is looking closely at how safe the medication is for children and how it affects platelet activity during these procedures.

What is already known about the treatment

Kengrexal 50 mg - Kengrexal is supplied as a powder that is mixed with liquid to create a solution for intravenous injection or infusion during a procedure. It is an approved short‑acting platelet inhibitor that is already used in adults and is being studied in children for safety and effectiveness. The drug is given to prevent blood clots when doctors perform diagnostic or therapeutic catheter procedures for congenital heart disease. It works by blocking a specific receptor (P2Y12) on platelets, which stops them from sticking together, and it belongs to the class of intravenous antiplatelet agents.

Investigated diseases

Congenital Heart Disease - Congenital heart disease is a structural problem of the heart that is present at birth. It includes holes in the walls, abnormal valves, or improper connections between chambers and vessels. These defects change the way blood moves through the heart and to the rest of the body. As the child grows, the heart may have to work harder, leading to changes in size or function. Some children show signs early, while others develop symptoms later in childhood. The condition can evolve over time, requiring ongoing observation of heart performance.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-523109-14-00Protocol codeCLI-06727AA1-03Estimated enrolment48 patientsSponsorChiesi Farmaceutici S.p.A.

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