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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Centro Cardiologico Monzino S.p.A.	Milan	Italy
IRCCS Policlinico San Donato	San Donato Milanese	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	05.04.2021

Trial locations

Investigated drugs:

I’m sorry, but the provided data does not include specific information about the medications or therapies involved in the clinical trial. If you have more detailed information or another source that lists the medications or therapies, please provide it so I can assist you further.

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 ID:

2024-518724-72-00

Protocol code:

PROMISE

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?