In short
There is currently 1 ongoing clinical trial investigating new treatment options for arteriospasm coronary, a condition where blood vessels in the heart suddenly tighten or narrow, causing chest pain. This trial is testing whether bosentan, a medication that helps relax blood vessels, can reduce the frequency and severity of these spasms in patients who continue to experience symptoms despite standard treatments. The trial is being conducted in the Netherlands. (Also known as: Coronary Artery Spasm, Coronary Vasospasm, Coronary Vasomotor Dysfunction)
Clinical trial locations
- Netherlands
Study on Bosentan for Treating Coronary Artery Spasm in Patients with Ongoing Angina Symptoms
This trial, known as EDIT-CAS, is investigating whether bosentan can help patients who experience coronary artery spasms. These spasms occur when the blood vessels in the heart suddenly tighten or narrow, reducing blood flow and causing chest pain or discomfort similar to angina. Even with standard medications like nitrates and calcium channel blockers, some patients continue to have these episodes regularly.
Main inclusion criteria:
- Adults aged 18 years or older
- Confirmed diagnosis of epicardial vasospasm through acetylcholine testing, which shows how the blood vessels on the heart's surface react to specific chemicals
- Currently receiving optimal standard care with at least two daily medications for chest pain
- Experiencing chest pain or similar symptoms at least once a week despite being on these medications
- Willingness to sign informed consent forms for both the trial and the NL-CFT registry
Main exclusion criteria:
- No confirmed diagnosis of coronary vasospasm or coronary vasomotor dysfunction
- Negative acetylcholine reactivity test for epicardial vasospasm
- No ongoing chest pain or angina-like symptoms
- Patients who are considered vulnerable and may need special protection
Focus and goals: The primary goal of this study is to determine whether bosentan can successfully reduce or eliminate coronary artery spasms. Participants will undergo an initial assessment to confirm their diagnosis, then receive either bosentan or a placebo for a 10-week treatment period. The medication comes in film-coated tablets at doses of either 62.5 mg or 125 mg. After the treatment period, participants will have a follow-up spasm provocation test to see if the vasospasm is still present. The study will also measure relief from chest pain symptoms and improvements in quality of life. Safety will be closely monitored through regular laboratory tests, blood pressure measurements, and tracking of any side effects or cardiovascular events.
Investigational drug: Bosentan is an endothelin receptor antagonist, which means it blocks certain substances in the body that cause blood vessels to tighten. By blocking these receptors, bosentan helps blood vessels stay relaxed and open, potentially preventing the sudden narrowing that causes coronary artery spasms. The medication is taken orally as a tablet and is being tested specifically to see if it can reduce the rate of spasms in patients whose symptoms persist despite standard treatment.
Summary
Currently, there is one clinical trial available for patients with arteriospasm coronary, located in the Netherlands. This trial represents an important investigation into alternative treatment options for patients who continue to experience coronary artery spasms despite receiving standard care. The study focuses on bosentan, an endothelin receptor antagonist that works differently from traditional antianginal medications like nitrates and calcium channel blockers. By blocking the substances that cause blood vessels to constrict, bosentan may offer a new approach to preventing these painful and potentially dangerous episodes. The trial is designed to provide clear evidence about whether this medication can successfully reduce or eliminate vasospasm, improve symptoms, and enhance quality of life for affected patients. The results of this study could potentially expand treatment options for this challenging condition.
