Study on Bosentan for Treating Coronary Artery Spasm in Patients with Ongoing Angina Symptoms

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What is this study about?

This clinical trial is focused on studying the effects of a medication called bosentan in treating a condition known as coronary artery spasm. This condition involves the sudden tightening or narrowing of the blood vessels in the heart, which can lead to chest pain or discomfort. The study will compare the effects of bosentan with a placebo to see if it can help reduce these spasms and improve symptoms in patients who continue to experience chest pain despite receiving standard treatments.

Participants in the study will be given either bosentan or a placebo in the form of oral tablets. The study will last for several weeks, during which time participants will take the medication regularly. Throughout the study, participants will undergo various assessments to monitor their heart health and any changes in their symptoms. The goal is to determine if bosentan can effectively reduce the frequency and severity of coronary artery spasms.

The study aims to provide valuable information on whether bosentan can be a beneficial addition to the current treatment options for coronary artery spasm. By comparing the outcomes between those taking bosentan and those taking a placebo, researchers hope to gain insights into the potential benefits of this medication for patients with this heart condition.

1 joining the study

Participation begins after signing the informed consent for the EDIT-CAS trial.

Eligibility requires a definitive diagnosis of epicardial vasospasm and ongoing angina-like complaints despite regular care.

2 initial assessment

An initial assessment is conducted to confirm the diagnosis of coronary vasospasm using acetylcholine reactivity testing.

Baseline measurements of angina symptoms and quality of life are recorded.

3 medication administration

Participants receive either bosentan or a placebo. Bosentan is administered orally in the form of film-coated tablets.

The dosage is either 62.5 mg or 125 mg, taken as prescribed by the study protocol.

4 treatment period

The treatment period lasts for 10 weeks.

Participants continue their regular care with antianginal medications alongside the study treatment.

5 follow-up assessment

A follow-up spasm provocation test is conducted to assess the presence of epicardial vasospasm.

The primary goal is to determine the absence of vasospasm according to specific criteria.

6 evaluation of outcomes

The primary outcome is the successful treatment of vasospasm.

Secondary outcomes include relief of angina symptoms and changes in quality of life.

7 safety monitoring

Safety is monitored through laboratory tests, blood pressure measurements, and tracking of any adverse events.

The occurrence of major adverse cardiovascular events and other issues is documented.

Who Can Join the Study?

Have a confirmed diagnosis of epicardial vasospasm using a maximum dose of 100 micrograms of acetylcholine. This means that the blood vessels on the heart’s surface have been shown to spasm during a specific test.
Be at least 18 years old.
Be receiving the best possible regular care, which includes current or past treatment with at least two daily medications for chest pain, such as nitrates and calcium channel blockers. These medicines help to relax and widen blood vessels.
Experience ongoing episodes of chest pain or similar symptoms at least once a week, even with the best possible regular care.
Have signed an online informed consent form to participate in the NL-CFT registry, or be willing to sign it at the time of joining the EDIT-CAS study. This means agreeing to have your information included in a research database.
Provide written informed consent to participate in the EDIT-CAS study. This means you agree to take part in the study after understanding what it involves.

Who Cannot Join the Study?

Patients who have not been diagnosed with coronary vasospasm or coronary vasomotor dysfunction. These are conditions where the blood vessels in the heart can suddenly tighten or spasm, reducing blood flow.
Patients who have not had a positive test for epicardial vasospasm using a specific test called acetylcholine reactivity testing. This test checks how the heart’s blood vessels react to a chemical called acetylcholine.
Patients who do not have ongoing angina-like complaints. Angina refers to chest pain or discomfort that occurs when the heart muscle doesn’t get enough blood.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Agpzbhvfm Uta	Amsterdam	The Netherlands
Slwwqzawx Rkkkuyk Uofloprusx Mgzqyvd Crdjym	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Bosentan is a medication used in this trial to see if it can help reduce the occurrence of coronary artery spasms. It works by blocking certain substances in the body that can cause blood vessels to narrow. This medication is being tested to see if it can help patients who have experienced these spasms and continue to have chest pain or discomfort.

Coronary Vasospasm – This condition involves a temporary, sudden narrowing of the coronary arteries, which can reduce blood flow to the heart muscle. It often occurs at rest and can cause chest pain similar to that of a heart attack. The spasms can be triggered by stress, cold exposure, or certain medications. Over time, repeated episodes may lead to damage to the heart muscle. The exact cause of coronary vasospasm is not fully understood, but it is believed to involve dysfunction of the endothelial cells lining the arteries.

Coronary Vasomotor Dysfunction (Spasm) – This condition refers to abnormal function of the coronary arteries, where they either constrict too much or fail to dilate properly. It can lead to reduced blood flow to the heart, causing chest pain or discomfort. The dysfunction can be due to an imbalance in the substances that control the contraction and relaxation of the blood vessels. It may occur in response to stress, cold, or certain drugs. Over time, this dysfunction can contribute to the development of heart disease. The underlying mechanisms are complex and involve both the smooth muscle cells and the endothelial cells of the arteries.

Trial ID:

2023-507782-25-00

Protocol code:

114746

Trial Phase:

Therapeutic use (Phase IV)

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Study on Bosentan for Treating Coronary Artery Spasm in Patients with Ongoing Angina Symptoms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?