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Study on Early vs. Delayed Ticagrelor with Cangrelor for Patients with STEMI Undergoing PCI

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 patients experiencing an , a type of heart attack. The study is investigating the use of two medications: and . Cangrelor is given as an injection or infusion, while ticagrelor is taken as a tablet. The purpose of the study is to find out if giving ticagrelor earlier, at the start of the cangrelor infusion, is more effective than giving it later, towards the end of the cangrelor infusion, in reducing the risk of high platelet reactivity. High platelet reactivity means that the blood cells responsible for clotting are more active than usual, which can be risky for heart attack patients.

Participants in the study will receive either an early or delayed dose of ticagrelor while they are also receiving cangrelor. The study will compare the effects of these two timing strategies on the patients' platelet activity. The researchers will also monitor for any major heart-related events, such as additional heart attacks or the need for further heart procedures, as well as any bleeding events, over a period of 30 days.

This study aims to improve the treatment approach for patients undergoing a procedure called , which is used to open blocked heart arteries during a STEMI. By understanding the best timing for administering ticagrelor, the study hopes to enhance patient outcomes and reduce complications associated with heart attacks.

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

    Joining the study

    Upon joining the study, the patient is diagnosed with ST-elevation myocardial infarction (STEMI) and is scheduled for a procedure called primary percutaneous coronary intervention (pPCI).

    The patient must be 18 years or older and provide informed consent to participate in the study.

  2. Step 2

    Medication administration

    The patient receives an intravenous infusion of cangrelor tetrasodium using a product called Kengrexal 50 mg powder for concentrate for solution for injection/infusion.

    During the cangrelor infusion, the patient is also administered an oral dose of ticagrelor using Brilique 90 mg film-coated tablets.

  3. Step 3

    Timing of ticagrelor administration

    The study aims to determine the best timing for administering ticagrelor. The patient is either given ticagrelor at the start of the cangrelor infusion or 30 minutes before the end of the infusion.

    This timing is crucial to assess its effect on reducing high platelet reactivity, which is a condition where blood platelets are more likely to form clots.

  4. Step 4

    Monitoring and assessment

    The primary goal is to measure the incidence of high platelet reactivity using a test called the platelet function analyzer (PFA)-200 P2Y test.

    The test measures the closure time (CT) of blood flow, with a CT of 106 seconds or less indicating high platelet reactivity.

  5. Step 5

    Follow-up and outcomes

    The study also monitors for secondary outcomes such as major adverse cardiovascular events, mortality, stent thrombosis, unplanned revascularization, peri-procedural infarction, and bleeding events within 30 days.

    The study is expected to conclude by December 31, 2025, with recruitment starting on June 1, 2024.

Who can join the trial?

7 criteria

  • The patient must have a diagnosis of ST-elevation myocardial infarction (STEMI). This is a type of heart attack.
  • The patient should be scheduled for a procedure called primary percutaneous coronary intervention (pPCI). This is a treatment to open blocked heart arteries.
  • The patient must be 18 years old or older.
  • The patient needs to provide informed consent, which means they agree to participate after understanding the study details.
  • There must be a clinical reason to give the patient two medications: cangrelor and ticagrelor. These are drugs used to prevent blood clots.
  • Both male and female patients can participate.
  • The study does not include vulnerable populations, which means groups that might need special protection.

Who cannot join the trial?

4 criteria

  • Patients who have had a recent heart attack called ST-elevation myocardial infarction (STEMI) and are undergoing a procedure to open blocked heart arteries, known as primary percutaneous coronary intervention (PCI).
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a specific clinical trial group that is not included in this study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Ticagrelor

    is a medication used to prevent blood clots in patients with heart conditions. In this study, it is given to patients with a type of heart attack called ST-segment elevation myocardial infarction (STEMI). The study is investigating whether giving ticagrelor earlier during another treatment can better reduce the risk of blood clots.

  • Cangrelor

    is a medication that helps prevent blood clots during certain heart procedures. It is given through an infusion, which means it is administered directly into the bloodstream. In this study, cangrelor is used in combination with ticagrelor to see if starting ticagrelor earlier can improve outcomes for patients undergoing a heart procedure called primary percutaneous coronary intervention (pPCI).

What is already known about the treatment

  • Ticagrelor

    Ticagrelor is an oral medication used to prevent blood clots in patients with heart conditions, particularly those experiencing a heart attack known as ST-elevation myocardial infarction (STEMI) who are undergoing a procedure called primary percutaneous coronary intervention (PCI). It is currently well-established in medical practice and literature as an antiplatelet agent. Ticagrelor works by inhibiting a receptor on platelets, which are small blood cells involved in clotting, thereby reducing their ability to clump together and form clots. It belongs to the pharmacological class of P2Y12 receptor antagonists.

  • Cangrelor

    Cangrelor is an intravenous medication used during certain heart procedures to prevent blood clots. It is particularly used in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Cangrelor is recognized in medical literature as a fast-acting antiplatelet agent. It works by blocking a specific receptor on platelets, preventing them from aggregating and forming clots. Cangrelor is classified as a P2Y12 receptor antagonist.

Investigated diseases

ST-elevation Myocardial Infarction (STEMI) – This is a type of heart attack characterized by a significant elevation in the ST segment on an electrocardiogram. It occurs when a coronary artery is completely blocked, preventing blood from reaching a part of the heart muscle. This blockage is usually due to a blood clot that forms on a ruptured plaque in the artery. As a result, the affected heart muscle begins to die if the blood flow is not restored quickly. The progression of STEMI can lead to severe damage to the heart muscle, affecting its ability to pump blood effectively. Immediate medical intervention, such as primary percutaneous coronary intervention (PCI), is crucial to restore blood flow and minimize heart damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511944-18-01Protocol codeARMYDA TICA-MIEstimated enrolment50 patientsSponsorAzienda Ospedaliero-Universitaria Maggiore Della Carita

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