In short
Clinical trials investigating 13N-AMMONIA are studying its use in people with refractory angina caused by obstructive coronary artery disease. These trials are looking at treatment response, exercise ability, angina episodes, and imaging results. The main study listed is a Phase 2 trial with 109 participants.
Key points
- Clinical trials investigating 13N-AMMONIA are focused on refractory angina caused by obstructive coronary artery disease. The main listed study is an authorised Phase 2 interventional trial with 109 participants. It compares outcomes after a one-time endocardial procedure against a sham procedure. The study measures exercise time, angina episodes, and ischemic burden on PET imaging. Results are assessed at Week 12 and Week 26 using a composite endpoint.
Trial overview
The available trial data show one authorised interventional study involving 13N-AMMONIA in people with refractory angina due to obstructive coronary artery disease. The study is called the EXACT-2 Trial and is listed as Phase 2 with an enrollment of 109 participants.
This trial is designed to evaluate the effects of XC001 in subjects with chronic angina caused by coronary artery disease, and 13N-AMMONIA is one of the listed study interventions. The data do not describe 13N-AMMONIA as the main treatment being tested, but it is part of the study setup.
Who is being studied
The target population is people with refractory angina due to obstructive coronary artery disease. Refractory angina means chest pain that keeps happening even when standard treatment has not fully helped.
The trial title also describes the population as subjects with chronic angina caused by coronary artery disease. This means the study is focused on people with long-lasting chest pain related to poor blood flow in the heart arteries.
Treatments and comparators
The intervention list includes Ammonia 13N given by intravenous administration, XC001 given by intracardiac use, and Flurpiridaz F 18 given by intravenous administration. The brief summary says the trial evaluates the effect of XC001 after a one-time endocardial administration compared with a sham procedure group.
A sham procedure is a comparison procedure that looks like treatment but does not include the active part being tested. This helps researchers see whether the treatment really changes symptoms and test results.
What the trials measure
The primary outcome is a composite endpoint based on the average of the proportions of subjects with a therapy response at Week 12 and Week 26 for XC001 compared with the sham procedure group. A composite endpoint combines several important results into one main study measure.
The brief summary says the study also looks at total exercise duration from a graded treadmill test, angina episodes recorded in a diary, and ischemic burden measured by PET stress imaging. These measures help show whether people can exercise longer, have fewer chest pain episodes, and have less reduced blood flow in the heart.
All treadmill and imaging results are assessed by blinded core labs. Blinded review means the people checking the results do not know which group the participant was in, which helps reduce bias.
Study design and phase
The study is listed as Phase 2 and interventional. Phase 2 trials are usually used to learn more about how well a treatment works and to continue collecting response data in a defined patient group.
The timing of the main response checks is at Week 12 and Week 26. This means the study follows participants over several months to see how outcomes change after the procedure.
What the results may mean
For patients, this trial is mainly about whether the study procedure can improve day-to-day symptoms and heart-related exercise limits in people with hard-to-treat angina. The main focus is not just one test result, but a mix of symptom reports, exercise testing, and imaging findings.
Because only one authorised trial is listed, the current evidence in the source data is limited to this Phase 2 study. The trial is still important because it uses several outcome measures to understand both how patients feel and how the heart performs during stress.