The goal of this clinical trial is to determine if N-acetylcysteine (NAC) can reduce angina frequency in women with Angina with Non-Obstructive Coronary Arteries (ANOCA). It will also assess the impact of NAC on health status and quality of life. The main questions it aims to answer are:
(i) Does NAC reduce the number of angina episodes per week? (ii) How does NAC affect quality of life and symptom burden in ANOCA patients? (iii) Does NAC reduce the need for short-acting nitrate use?
Researchers will compare NAC to a placebo in a randomized, double-blind, placebo-controlled crossover study to determine its effectiveness.
Participants will receive treatment with NAC 600mg twice daily for 4 weeks (28 days) and matched placebo for 4 weeks (28 days) in a computer-generated random order giving a total dosing period of 8 weeks. There will be a 2-week washout between the two treatment periods.
The effectiveness of N-Acetylcysteine (NAC) will be assessed using the following measures:
Angina Diary: Participants will record the frequency and severity of their angina episodes.
Seattle Angina Questionnaire-7 (SAQ-7): Participants will complete this questionnaire to assess physical limitations, angina frequency, and quality of life.
EuroQol 5-Dimension (EQ-5D) Questionnaire: Participants will rate their overall health and quality of life.
Provision of informed consent prior to any study specific procedures
Female patients aged ≥18 years
No obstructive CAD (defined as either absence of epicardial lesions with ≥50% luminal narrowing in any coronary artery segment on coronary angiography or normal findings on computed tomography (CT) angiogram, indicating the absence of significant stenosis) to account for chest pain symptoms.
Chest pain occurring ≥3 times/week in the preceding two weeks.
Known allergy to NAC or its components.
Acute myocardial infarction admission within the preceding month (hospital admission for prolonged angina paint associated with a cardiac troponin level above the 99th percentile, with a subsequent rise or fall).
Crossover
N-Acetylcysteine (NAC)
DrugThe investigational product for this study is NAC 600 mg capsules. The NAC drug substance is sourced from a Good Manufacturing Practice (GMP)-certified supplier by Syntro Health Pty Ltd and tested on receipt
Placebo
DrugTo ensure appropriate blinding and to match the physical characteristics of the NAC capsules, the placebo capsules will be filled with dicalcium phosphate (DCP). DCP has been selected over microcrystalline cellulose due to the weight requirements of the NAC formulation.
Frequency of angina episodes recorded in angina diary.
Number of angina episodes recorded in angina diary. The angina diary is developed to record the frequency, duration, severity, and reliever of chest pain episodes. Participant record their angina episodes throughout the study period.
Frequency of Short-acting nitrate consumption (i.e., Glyceryl trinitrate (GTN) spray use)
Short-acting nitrate consumption (i.e., Glyceryl trinitrate (GTN) spray use), self reported on angina diary
Frequency of prolonged angina episodes (ie episodes persisting > 20 minutes)
Frequency of prolonged angina episodes (ie episodes persisting \> 20 minutes) assessed from patient's self reported angina diary
Angina frequency score as assessed by Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) is a tool used to assess the health-related quality of life in patients with angina, especially those with coronary artery disease (CAD). Patients report the frequency of their angina episodes, including both exertional and spontaneous chest pain, based on structured response options. The score is then converted to a 0-100 scale, with higher scores indicating less frequent angina and better symptom control.
Angina-related physical limitations score as assessed on Seattle Angina Questionnaire
The Angina-Related Physical Limitations Score is a subscale of the Seattle Angina Questionnaire (SAQ) that evaluates the extent to which angina symptoms restrict a patient's ability to perform daily physical activities. Patients rate the difficulty they experience in performing activities such as walking, climbing stairs, or carrying groceries due to their angina. Responses are scored on a 0-100 scale, where higher scores indicate fewer physical limitations and better functional status.
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