Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effects of Warfarin, Lysine Aspirin, and Clopidogrel in Patients with Myocardial Infarction and Non-Obstructive Coronary Arteries (MINOCA)

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

What is this trial about?

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

This clinical trial is focused on studying a condition known as Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA). This condition involves a heart attack where the coronary arteries are not significantly blocked. The study aims to explore if a personalized approach to understanding the cause of MINOCA and providing treatment based on that cause can improve the quality of life for patients.

The trial will involve several medications, including warfarin, Lysine Aspirin, Clopidogrel, Acetylsalicylic Acid, Atorvastatin, Diltiazem, Bisoprolol, Acetylcholine Chloride, Glyceryl Trinitrate, and ramipril. These medications are used for various purposes such as preventing blood clots, reducing cholesterol, and managing heart conditions. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual medications.

Participants in the study will be monitored over a period of 12 months. During this time, their angina status and quality of life will be assessed using a questionnaire. The study will also track any major cardiovascular events, such as heart attacks or strokes, and evaluate the costs associated with healthcare for MINOCA patients. Additionally, the study will investigate the use of certain biomarkers, which are substances in the blood that can help diagnose and understand the causes of MINOCA, as well as the use of Cardiac Magnetic Resonance Imaging (CMR) to evaluate the condition. The goal is to gather information that could lead to better treatment strategies for people with MINOCA.

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 assessment

    Upon joining the study, you will undergo an initial assessment to confirm your eligibility. This includes reviewing your medical history and ensuring you meet the criteria for participation, such as being over 18 years old and having a diagnosis of myocardial infarction with non-obstructive coronary arteries (MINOCA).

  2. Step 2

    Medication administration

    You will be prescribed specific medications based on the study protocol. These may include warfarin, lysine aspirin, clopidogrel, acetylsalicylic acid, atorvastatin, diltiazem, bisoprolol, acetylcholine chloride, glyceryl trinitrate, and ramipril. Most of these medications are taken orally, while acetylcholine chloride is administered through intra-arterial use.

  3. Step 3

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and possibly imaging tests to assess your heart condition.

  4. Step 4

    Quality of life assessment

    Your quality of life will be evaluated using the Seattle Angina Questionnaire (SAQ) at the one-year follow-up. This questionnaire helps to assess your angina status and overall well-being.

  5. Step 5

    Monitoring for adverse events

    Throughout the study, you will be monitored for any major adverse cardiovascular events, such as heart attacks, strokes, or heart failure. This monitoring helps to ensure your safety and the effectiveness of the treatment.

  6. Step 6

    Biomarker analysis

    Blood samples may be taken to analyze specific biomarkers, which are substances in your blood that can provide information about your heart condition. These biomarkers include ET-1, NPY, CRP, sCD40L, and various miRNAs.

  7. Step 7

    Final evaluation

    At the end of the study, a final evaluation will be conducted to assess the overall outcomes of the treatment and its impact on your health and quality of life.

Who can join the trial?

5 criteria

  • Ability to give informed consent to the study. This means you understand the study and agree to participate.
  • Age over 18 years.
  • Diagnosis of MINOCA (Myocardial Infarction with Non-Obstructive Coronary Arteries), which includes:
    • Acute myocardial infarction: A heart attack, as defined by specific medical criteria.
    • Evidence of non-obstructive coronary artery disease: This means that during a heart examination called angiography, there is no significant blockage (less than 50% narrowing) in the major heart arteries.
    • No other specific diagnosis for the symptoms: This means that other causes for heart injury, like infections or blood clots in the lungs, have been ruled out.

Who cannot join the trial?

3 criteria

  • Patients who have had a recent heart attack but do not have blocked heart arteries cannot participate.
  • Patients who are under 18 years old or over 65 years old are not eligible.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are excluded.
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Acetylsalicylic acid

    , widely known as aspirin, is used in this trial both as a tablet taken by mouth and as a fast-acting form given into a vein. In low doses it makes the blood platelets less sticky, so they are less likely to clump together and form clots in the arteries of the heart. It is a cornerstone medicine for preventing heart attacks and is given here to protect patients who have had a heart attack without blocked arteries.

  • Clopidogrel

    is an antiplatelet tablet taken once a day. It blocks a switch on the surface of the platelets so that they cannot stick together and form clots inside blood vessels. In this trial it is used, often together with aspirin, for patients whose heart attack is thought to have been caused by a clot or a tear in the vessel wall.

  • Warfarin

    is a blood-thinning tablet that has been used for decades. It lowers the production of several clotting factors in the liver that depend on vitamin K, which makes the blood clot more slowly; regular blood tests are needed to keep the effect in the right range. In this trial it is given when the heart attack is believed to have been caused by a clot that travelled to the heart, for example from the heart chambers.

  • Atorvastatin

    is a cholesterol-lowering tablet from the statin family. It blocks an enzyme in the liver that produces cholesterol, which lowers the level of harmful cholesterol in the blood and helps stabilise the walls of the arteries. In this trial it is used to prevent further heart problems in patients after their heart attack.

  • Bisoprolol

    is a beta-blocker tablet. It slows the heartbeat and reduces the force with which the heart pumps, lowering blood pressure and the heart's workload and need for oxygen. In this trial it is given to selected patients to protect the heart and prevent chest pain.

  • Diltiazem

    is a calcium-channel blocker taken as tablets or capsules. It relaxes the muscle cells in the walls of the heart arteries, widening them and preventing them from going into spasm. In this trial it is the key treatment for patients whose heart attack was caused by a temporary spasm of a coronary artery.

What is already known about the treatment

WARFARIN - Warfarin is taken by mouth as tablets. It is a well-known and extensively studied medication used to prevent blood clots in patients with myocardial infarction (heart attack) or atrial fibrillation. It works by blocking the use of vitamin K, which reduces the production of clotting factors. It belongs to the group of oral anticoagulants. LYSINE ASPIRIN - Lysine aspirin is given intravenously as a solution. It is an approved preparation used in hospital for the emergency treatment of myocardial infarction. It works by inhibiting an enzyme involved in producing the substances that make platelets clump together, thereby reducing clot formation. It belongs to the class of antiplatelet agents (NSAIDs). CLOPIDOGREL - Clopidogrel is taken by mouth, as tablets. It is a well-established medication recommended after myocardial infarction or coronary procedures. It blocks the P2Y12 receptor on platelets, preventing their activation and the formation of clots. It is part of the thienopyridine class of antiplatelet agents. ACETYLSALICYLIC ACID - Acetylsalicylic acid (aspirin) is taken orally, usually as 100 mg tablets. It is a very old and very well documented medication used for cardiovascular protection. It inhibits the enzyme that allows the production of prostaglandins, reducing platelet aggregation. It is classified as a non-steroidal anti-inflammatory drug and antiplatelet agent. ATORVASTATIN - Atorvastatin is taken orally, as tablets. It is a widely used medication, supported by numerous studies, for lowering cholesterol and preventing heart disease. It works by blocking the enzyme HMG-CoA reductase, reducing cholesterol production in the liver. It belongs to the group of statins, lipid-lowering agents. DILTIAZEM - Diltiazem is taken by mouth, as tablets. It is a well-known medication for treating angina and high blood pressure. It blocks the entry of calcium into the muscle cells of the heart and blood vessels, which relaxes the vessels and lowers the heart rate. It belongs to the class of calcium channel blockers. BISOPROLOL - Bisoprolol is taken orally, as tablets. It is a beta-blocker frequently used in the treatment of high blood pressure and heart failure. It blocks the beta-1 receptors in the heart, lowering the rate and force of its contractions. It is part of the beta-blocker group. ACETYLCHOLINE CHLORIDE - Acetylcholine chloride is administered intra-arterially, by injection directly into an artery. It is used mainly in diagnostic tests to assess how blood vessels react. It binds to muscarinic receptors, causing relaxation of the vascular smooth muscle. It is classified as a cholinergic agent. GLYCERYL TRINITRATE - Glyceryl trinitrate is taken orally, usually as sublingual tablets. It is an established medication for relieving angina pain. It releases nitric oxide, which relaxes the blood vessels and reduces the workload of the heart. Within the category of vasodilators, it is a nitrate. RAMIPRIL - Ramipril is taken orally, as tablets. It is an angiotensin-converting enzyme (ACE) inhibitor that is very widely used and well studied in post-infarction therapy. It blocks the formation of angiotensin II, reducing blood vessel constriction and blood pressure. It belongs to the group of ACE inhibitors.

Investigated diseases

Myocardial infarction with non-obstructive coronary arteries (MINOCA) – This condition occurs when there is evidence of a heart attack, but the coronary arteries do not show significant blockage. It is characterized by chest pain and elevated cardiac biomarkers, similar to a typical heart attack. The progression involves damage to the heart muscle due to reduced blood flow, despite the absence of major artery obstruction. Various mechanisms can contribute to MINOCA, including coronary artery spasm, microvascular dysfunction, or plaque disruption. The condition can lead to ongoing symptoms like angina and may affect the patient's quality of life. Understanding the underlying cause is crucial for managing the disease effectively.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518724-72-00Protocol codePROMISEEstimated enrolment145 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.