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Study on Cangrelor and Bivalirudin for Patients with Heart Attack-Related Cardiogenic Shock or Cardiac Arrest on VA-ECMO Support

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 studying the treatment of patients experiencing a severe heart condition known as myocardial infarction, commonly referred to as a heart attack, which has led to a serious complication called cardiogenic shock or cardiac arrest. These patients require a special type of life support called VA-ECMO (Veno-Arterial Extracorporeal Membrane Oxygenation), which helps their heart and lungs function. The study is testing a treatment that combines two medications: cangrelor and bivalirudin. Cangrelor is given as an injection or infusion and is used to prevent blood clots, while bivalirudin is another medication that helps prevent clotting during medical procedures.

The purpose of this study is to evaluate how well this combination of medications works in preventing blood clots and reducing the risk of bleeding in patients undergoing a procedure called PCI (Percutaneous Coronary Intervention), which is often used to treat heart attacks. The study will monitor patients to see if the treatment effectively prevents clotting issues and minimizes bleeding problems. Patients will receive cangrelor and bivalirudin, with the doses adjusted based on specific tests that measure how well the blood is clotting.

Throughout the study, the focus will be on ensuring the safety and effectiveness of the treatment. The study will track any occurrences of blood clots or bleeding events while patients are receiving cangrelor. The goal is to find a balance where the treatment is effective in preventing clots without causing significant bleeding. This research aims to improve the care and outcomes for patients with severe heart conditions requiring advanced support like VA-ECMO.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be adults aged 18 or older, experiencing severe heart failure due to a heart attack, and requiring extracorporeal circulatory support.
Participants should have received a pre-hospital intravenous aspirin loading dose or be new to any anti-thrombotic agent.
Step 2
Treatment initiation
The treatment involves the administration of two medications: bivalirudin and cangrelor. These medications are used to prevent blood clots and reduce bleeding risks.
Bivalirudin is administered to maintain a specific blood clotting time, measured in seconds.
Step 3
Cangrelor administration
Cangrelor is given intravenously, starting at a dose of 0.125 micrograms per kilogram per minute. The dose may be adjusted by increments of 0.125 micrograms per kilogram per minute based on platelet function tests.
The goal is to balance the prevention of blood clots with minimizing bleeding risks.
Step 4
Monitoring and adjustments
Throughout the treatment, regular monitoring is conducted to assess the effectiveness and safety of the therapy.
Adjustments to medication dosages are made based on test results to ensure optimal outcomes.
Step 5
Evaluation of outcomes
The primary focus is on the occurrence of thrombotic events (blood clots) and bleeding events during the cangrelor infusion period.
Major bleeding events are specifically monitored and defined according to established research criteria.

Who can join the trial?

6 criteria

Patients must be **18 years or older**.
Patients must have **ACS-related CS/CA**. This means they have a heart condition called **Acute Coronary Syndrome (ACS)** that has led to **Cardiogenic Shock (CS)** or **Cardiac Arrest (CA)**.
Patients must be undergoing a procedure called **PCI**. This is a treatment to open up blood vessels in the heart, sometimes involving a small tube called a **stent**.
Patients must need **VA-ECMO support**. This is a machine that helps the heart and lungs work better.
Patients must have received a **pre-hospital aspirin i.v. loading dose**. This means they were given aspirin through a vein before reaching the hospital.
Alternatively, patients can be **naïve to any anti-thrombotic agent**. This means they have not taken any medication that prevents blood clots before.

Who cannot join the trial?

5 criteria

Patients who are not adults cannot participate.
Patients who are not undergoing treatment with VA ECMO for heart-related issues like cardiogenic shock or cardiac arrest cannot participate. Cardiogenic shock is a condition where the heart suddenly can't pump enough blood, and cardiac arrest is when the heart stops beating.
Patients who are not undergoing a procedure called PCI cannot participate. PCI stands for percutaneous coronary intervention, a procedure to open blocked heart arteries.
Patients who are not receiving specific medications like bivalirudin and cangrelor cannot participate. Bivalirudin is a medication that helps prevent blood clots, and cangrelor is a drug that prevents platelets in the blood from clumping together.
Patients who are part of a vulnerable population cannot participate. This means people who might be at higher risk of harm or exploitation.

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Ospedale San Raffaele S.r.l.
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Milan, Italy

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Investigated drugs

Bivalirudin
is a medication used to prevent blood clots. In this trial, it is part of a treatment plan to help patients who have had a heart attack and are receiving special heart support. The goal is to prevent clots while minimizing bleeding risks.
Cangrelor
is another medication used to prevent blood clots. It works quickly and is used in combination with bivalirudin in this study. The combination aims to effectively prevent clotting events in patients undergoing heart procedures while they are on heart support.

Cangrelor Tetrasodium

What is already known about the treatment

Cangrelor
Cangrelor is administered intravenously and is used in the context of acute cardiac conditions. It is currently being studied for its effectiveness and safety in patients experiencing cardiogenic shock or cardiac arrest who are undergoing percutaneous coronary intervention (PCI) while receiving VA-ECMO support. The main therapeutic indication for cangrelor is to prevent thrombotic events in these patients. At the molecular level, cangrelor works by inhibiting the P2Y12 receptor on platelets, which prevents platelet activation and aggregation. It is classified as an antiplatelet medication.
Bivalirudin
Bivalirudin is administered intravenously and is used as an anticoagulant in various medical settings. In the context of the clinical trial, it is being evaluated for its role in combination with cangrelor to manage patients with myocardial infarction-related cardiogenic shock or cardiac arrest undergoing PCI with VA-ECMO support. The main therapeutic indication is to provide anticoagulation while minimizing bleeding risks. Bivalirudin acts by directly inhibiting thrombin, an enzyme involved in blood clot formation. It is classified as a direct thrombin inhibitor.

Investigated diseases

Cardiogenic Shock
This condition occurs when the heart suddenly cannot pump enough blood to meet the body's needs, often due to a severe heart attack. It leads to reduced blood flow to vital organs, causing symptoms like rapid breathing, confusion, and weak pulse. As the condition progresses, it can result in organ failure if not managed promptly. Cardiogenic shock requires immediate medical attention to restore blood flow and support heart function.
Cardiac Arrest
This is a sudden loss of heart function, breathing, and consciousness, usually resulting from an electrical disturbance in the heart. It disrupts the heart's pumping action, stopping blood flow to the body. Without immediate intervention, such as CPR or defibrillation, cardiac arrest can lead to death within minutes. It is a medical emergency that requires urgent treatment to restore heart rhythm and blood circulation.