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A study of tirofiban and adenosine to treat small blood vessel damage in patients with ST-elevation myocardial infarction

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What is this trial about?

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

This study focuses on individuals who have experienced a ST-elevation myocardial infarction, which is a serious type of heart attack caused by a complete blockage of a coronary artery. A common complication following this event is microvascular obstruction, a condition where damage occurs to the smallest blood vessels in the heart muscle, preventing proper blood flow even after the main artery is opened. The purpose of this study is to evaluate a system designed to deliver medications directly into these small vessels to treat this injury.

Participants in the study may receive adenosine, tirofiban, or a placebo. These substances are administered through a process called intracoronary infusion, which means the medicine is delivered directly into the heart's arteries using a specialized catheter. The study involves comparing the effects of these treatments against a control group to see how they influence heart recovery.

During the course of the study, the left ventricular ejection fraction, which is a measurement of how well the heart pumps blood out to the body, will be monitored. Changes in how the heart muscle moves and functions will be observed over a period of several months to assess the impact of the treatments on the heart's ability to recover after the initial injury.

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

    <b>initial medical procedure</b>

    A primary percutaneous coronary intervention (PPCI), which is a procedure to open blocked heart arteries, is performed.

    During this procedure, the CoFI system is used to deliver medication directly into the heart's small blood vessels through intracoronary infusion (injecting medicine into the coronary artery).

  2. Step 2

    <b>medication administration</b>

    The adenosine medication is administered at a dose of 300 micrograms via intracoronary use (injection into the heart artery).

    The tirofiban medication is administered at a dose of 25 micrograms per kilogram of body weight via intracoronary infusion (a slow drip into the heart artery).

  3. Step 3

    <b>early monitoring and assessments</b>

    Between 24 to 72 hours after the initial procedure, an echocardiography (TTE), which is an ultrasound of the heart, is performed to measure the left ventricular ejection fraction (LVEF). this measurement shows how well the heart pumps blood.

    The regional wall motion score index (RWMSI), which evaluates how the heart muscle moves in the area affected by the injury, is also assessed during this time.

  4. Step 4

    <b>short-term safety follow-up</b>

    At 30 days after the procedure, safety is evaluated regarding any complications related to the device, the procedure, or issues like thrombus (blood clots) or vessel closure.

  5. Step 5

    <b>long-term follow-up</b>

    At 6 months after the procedure, another echocardiography (TTE) is performed to measure the left ventricular ejection fraction (LVEF) and the regional wall motion score index (RWMSI) to track the long-term effects on heart function and muscle movement.

Who can join the trial?

11 criteria

  • You must be 18 years of age or older.
  • You must be able to provide informed consent, which means you understand the study and agree to participate.
  • You must have a blockage in the proximal or mid section of the left anterior descending coronary artery, which is a major blood vessel that supplies blood to the front of the heart.
  • Your electrocardiogram (ECG), which is a test that records the electrical activity of your heart, must show signs of an acute anterior myocardial infarction, meaning a sudden heart attack affecting the front part of the heart.
  • Your ECG must show ST-elevation, a specific pattern in the heart's electrical signal that indicates heart muscle damage, of at least 2 mm in men or 1.5 mm in women across specific leads.
  • The time from when your symptoms started to when the balloon was used to open the artery must be 6 hours or less.
  • Your symptoms may include myocardial ischemia, which is when the heart muscle does not get enough oxygen-rich blood, causing chest pain, shortness of breath, nausea, or fainting.
  • You must be a suitable candidate for Primary PCI, which is an emergency procedure used to open blocked heart arteries using a tiny balloon and a mesh tube called a stent.
  • An angiogram, which is an X-ray test that shows how blood flows through your arteries, must show a culprit lesion, which is the specific area of blockage causing the heart attack, that is suitable for a stent.
  • The CoFI balloon, a special medical device used in this study, must be able to be placed correctly according to the manufacturer's instructions.
  • The stent, a small mesh tube used to keep the artery open, must have a diameter between 2.75 mm and 5 mm and a length of at least 15 mm.

Who cannot join the trial?

25 criteria

  • Being unconscious, which means being unable to wake up or respond to people.
  • Having a known coagulopathy, which is a condition that prevents your blood from clotting properly.
  • Taking oral anticoagulation therapy, which refers to medicines taken by mouth to thin the blood.
  • Needing a machine to help you breathe or a machine to help your blood circulate.
  • Having experienced cardiac arrest, where the heart stops beating, for more than 5 minutes and required cardiopulmonary resuscitation (CPR).
  • Having heart failure that requires inotrope support (medicines to help the heart pump stronger) or being considered for a left ventricular assist device (LVAD) or a heart transplant.
  • Having other serious illnesses like cancer or dementia, or a history of substance abuse, which might make it hard to follow the study rules or may result in a life expectancy of less than one year.
  • Currently participating in a different clinical study.
  • Being pregnant or currently breastfeeding.
  • Having items in the body that prevent the use of a Cardiac MRI (a detailed imaging test of the heart), such as a pacemaker, defibrillator, insulin pump, or any other implanted metal devices.
  • Having metal shavings in the eyes or any metal fragments like shrapnel or bullets in a dangerous location.
  • Being unable to hold your breath for at least 15 seconds during imaging.
  • Having an allergy or sensitivity to gadolinium, which is a special dye used during MRI scans.
  • Having severe kidney disease, specifically an estimated glomerular filtration rate (eGFR) of less than 30, or being on haemodialysis (a machine that cleans your blood).
  • Having heart vessels that are too twisted, too diseased, or have too much calcification (hard calcium buildup) to allow medical tools to pass through easily.
  • Being under judicial protection or legal guardianship.
  • Having a heart condition that prevents the use of the CoFI system (the medical device being studied).
  • Requiring specific extra medicines during a procedure that are not part of the standard treatment.
  • Having a mental disorder or a language barrier that makes it impossible to fully understand and agree to the study.
  • Having a pericardial effusion or cardiac tamponade, which is an abnormal buildup of fluid around the heart that puts pressure on it.
  • Experiencing cardiogenic shock, a condition where the heart suddenly cannot pump enough blood to the body, often marked by very low blood pressure or poor blood flow to organs.
  • Having a history of a previous myocardial infarction (MI), which is a heart attack, or cardiomyopathy (a disease of the heart muscle).
  • Having a ventricular pseudoaneurysm, a ventricular septal defect (a hole in the heart wall), or severe problems with the heart valves.
  • Having experienced major bleeding or major surgery within the last 30 days.
  • Having a history of a stroke, a TIA (a temporary blockage of blood to the brain), or other brain-related blood flow issues within the last 6 months.
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Investigated drugs

  • Adenosine

    is a medication used in this study through an injection into the heart's blood vessels to help treat damage to the tiny blood vessels in the heart.

  • Tirofiban

    is a medication used in this study through an infusion into the heart's blood vessels to help treat damage to the tiny blood vessels in the heart.

What is already known about the treatment

  • Adenosine

    This medication is an injection given directly into the heart's arteries to help manage certain heart conditions. It is a well-established substance used in medical practice to temporarily slow down the electrical activity in the heart or to test how blood flows through the coronary arteries. On a molecular level, it works by binding to specific sensors on the surface of heart cells, which helps relax the smooth muscles in the blood vessel walls and widen them. It is classified as an antiarrhythmic and a vasodilator.

  • Tirofiban

    This medication is administered as an infusion directly into the coronary arteries to help prevent blood clots from forming. It is currently used in clinical settings to treat patients experiencing serious heart attacks or unstable chest pain. It works by blocking a specific protein on the surface of blood platelets, which prevents these tiny blood cells from sticking together and creating dangerous blockages. This drug is classified as an antiplatelet agent.

Investigated diseases

ST-segment elevation myocardial infarction - This is a serious type of heart attack that occurs when a coronary artery is completely blocked. The blockage prevents blood and oxygen from reaching a part of the heart muscle. As a result, the muscle cells in that area begin to suffer damage. This condition is often identified by specific changes in the heart's electrical activity. If the blood flow is not restored, the damaged area of the heart muscle may lose its ability to contract properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522060-32-00Protocol code2503Estimated enrolment280 patients

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).