Not recruiting

Study on the Effects of Metoprolol, Prasugrel, and Carbasalate Calcium in Patients with Spontaneous Coronary Artery Dissection

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 effects of certain medications on patients with Spontaneous Coronary Artery Dissection (SCAD). SCAD is a condition where a tear forms in one of the blood vessels in the heart, which can lead to heart attacks or other heart-related issues. The study will explore the use of two types of medications: Beta-Blockers and Antiplatelet Agents. Beta-Blockers, such as Metoprolol, Propranolol, Atenolol, Carvedilol, and Bisoprolol, are commonly used to manage heart conditions by slowing down the heart rate and reducing blood pressure. Antiplatelet Agents, including Carbasalate Calcium, Prasugrel, Telmisartan, and Ticagrelor, help prevent blood clots by stopping platelets in the blood from sticking together.

The purpose of this study is to assess how effective these medications are in treating patients with SCAD. Participants in the study will be randomly assigned to receive either the active medication or a placebo. The study will last for up to 12 months, during which participants will take the medication orally. Throughout the study, participants will be monitored for any changes in their condition, and the effects of the medication will be evaluated.

By participating in this study, researchers aim to gather valuable information on the potential benefits and safety of using Beta-Blockers and Antiplatelet Agents in managing SCAD. This research could lead to improved treatment options for individuals affected by this condition. The study will also look at various outcomes, such as the occurrence of heart attacks, strokes, or the need for additional heart procedures, to determine the overall effectiveness of the treatment strategy.

The research process

The trial runs in 4 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, the patient must provide written informed consent. This is a document that confirms understanding and agreement to participate in the trial.
The patient must have been admitted for acute coronary syndrome (ACS) or another form of heart-related chest pain, and have a diagnosis of spontaneous coronary artery dissection (SCAD) confirmed by a coronary angiography during their initial hospital stay.
Step 2
Medication administration
The patient will be administered medications orally. These include beta-blockers such as metoprolol, propranolol, atenolol, carvedilol, and bisoprolol. Beta-blockers help manage heart conditions by slowing down the heart rate and reducing blood pressure.
The patient will also receive antiplatelet agents like acetylsalicylic acid, prasugrel, clopidogrel, and ticagrelor. These medications help prevent blood clots by stopping platelets from sticking together.
Step 3
Monitoring and follow-up
Throughout the trial, the patient's health will be monitored to assess the effectiveness of the treatment. This includes checking for any major health events such as death, heart attack, stroke, need for coronary revascularization, recurrent dissection, or hospital admission for ACS or heart failure.
The trial will also evaluate the safety of the treatment by monitoring for any bleeding events, which will be defined according to specific medical criteria.
Step 4
Completion of the trial
The trial is expected to conclude by February 28, 2026. At the end of the trial, the combined results will be analyzed to determine the overall effectiveness and safety of the treatment strategy.

Who can join the trial?

6 criteria

Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
Have been admitted to the hospital for ACS (Acute Coronary Syndrome) or any other signs of myocardial ischemia, which is when the heart muscle doesn't get enough blood.
Have a diagnosis of SCAD (Spontaneous Coronary Artery Dissection) confirmed by a coronary angiography, a special X-ray test that looks at the heart's blood vessels, during your current hospital stay.
Be within the age range of 18 to 64 years old.
Both female and male participants are eligible.
Individuals considered part of a vulnerable population are also eligible, meaning those who might need special protection or care.

Who cannot join the trial?

9 criteria

Patients who have had a recent heart attack or stroke.
Individuals with severe heart failure, which means the heart is not pumping blood as well as it should.
People with uncontrolled high blood pressure, meaning their blood pressure is too high despite treatment.
Patients with severe liver or kidney disease, which affects how the body processes medications.
Individuals who are pregnant or breastfeeding.
People who have a known allergy to the medications being tested in the study.
Patients who are currently participating in another clinical trial.
Individuals with a history of drug or alcohol abuse.
People with any other medical condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario De Jaen
Responsive
Jaen, Spain

Trial locations

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Investigated drugs

Beta-Blockers
are medications that help reduce the heart's workload and lower blood pressure. They work by blocking the effects of adrenaline, which slows down the heart rate and helps the heart beat more regularly. In this trial, they are being used to see if they can help patients with Spontaneous Coronary Artery Dissection (SCAD) by reducing stress on the heart and preventing further complications.
Antiplatelet Agents
are medications that prevent blood cells called platelets from clumping together to form clots. These agents are important in reducing the risk of heart attacks and strokes by keeping the blood flowing smoothly through the arteries. In this trial, they are being evaluated for their effectiveness in preventing complications in patients with Spontaneous Coronary Artery Dissection (SCAD).

What is already known about the treatment

Beta-Blockers
These medications are typically administered orally in tablet form. They are widely used in medicine to manage various cardiovascular conditions, including high blood pressure and heart rhythm disorders. In the context of this clinical trial, they are being evaluated for their effectiveness in treating Spontaneous Coronary Artery Dissection (SCAD). Beta-blockers work by blocking the effects of adrenaline on the heart, which slows the heart rate and reduces blood pressure, thereby decreasing the heart's demand for oxygen. They belong to the pharmacological class of beta-adrenergic blocking agents.
Antiplatelet Agents
These drugs are usually taken orally and are designed to prevent blood clots by inhibiting platelet aggregation. They are well-established in medical practice for preventing strokes and heart attacks. In this trial, they are being tested for their potential benefits in patients with Spontaneous Coronary Artery Dissection (SCAD). Antiplatelet agents work by interfering with the chemical signals that prompt platelets to clump together, thus reducing the risk of clot formation. They are classified under antithrombotic agents.

Investigated diseases

Spontaneous Coronary Artery Dissection – This condition occurs when a tear forms in one of the coronary arteries, which supply blood to the heart. The tear can cause blood to flow between the layers of the artery wall, leading to a blockage or reduced blood flow to the heart muscle. This can result in chest pain, heart attack, or other heart-related symptoms. The progression of the disease can vary, with some cases resolving on their own while others may lead to more severe complications. It is more commonly seen in women, particularly those who are pregnant or have recently given birth. The exact cause of the tear is not always clear, but it may be related to hormonal changes, high blood pressure, or other underlying conditions.