Angina AttacksPhase 2NANANCT06890507
The Anti-Anginal Effects of N-Acetylcysteine (NAC) in Patients with Angina and Non-Obstructive Coronary Arteries (ANOCA)
A Phase 2 study testing N-Acetylcysteine (NAC) in people with Angina Attacks and Non Obstructive Coronary Artery Disease, run by University of Adelaide at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Angina Attacks, Non Obstructive Coronary Artery Disease
- What is being tested?
- N-Acetylcysteine (NAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2025to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Secondary causes of angina including:
- clinically significant anaemia (haemoglobin <100g/dL) ii. uncontrolled atrial fibrillation (ventricular response rate >108bpm) iii. haemodynamically significant aortic stenosis (mean valve gradient ≥40mmHg) d) Known concomitant disease with life expectance of less than 1 year. e) Abnormalities in liver function tests suggesting hepatic impairment (ALT and/or AST 2 x upper limit of normal (ULN) or ALP 2 x ULN or Bilirubin 1.5 x ULN) f) Severe renal impairment (eGFR <30mL/min) or on dialysis. g) Pregnancy or lactation. h) Untreated hypertension i) Unwilling, or unable, to give informed consent, including due to severe psychiatric conditions affecting informed consent process or compliance.
- History of substance abuse. k) Currently taking Chloroquine. l) Serious or unstable medical conditions that may interfere with the study, as determined by the PI.
- Concomitant participation in another clinical trial or research study (except where in the opinion of the PI, the participant could benefit from enrolling in another trial)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
About this study
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?
Read more
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.
Read the detailed description
Background:
Angina with Non-Obstructive Coronary Arteries (ANOCA) refers to a condition where patients experience chronic angina despite having no significant coronary artery blockages. This condition affects 50-70% of women undergoing elective angiography, in stark contrast to just 7-17% of men. Many experience a prolonged delay in diagnosis, resulting in notable decreases in functional capacity.
NAC has been shown to reduce oxidative stress and potentiate the vasodilatory and antiaggregatory effects of nitrates, potentially reducing microvascular damage and improving myocardial perfusion, hence presenting a promising therapeutic option for ANOCA patients. Although there are no established clinical guidelines for ANOCA management, standard therapy typically includes both long-acting and short-acting nitrates to alleviate anginal symptoms. However, many ANOCA patients continue to experience symptoms despite standard therapy. As such, this trial will assess the beneficial effects of NAC therapy in ANOCA women.
Primary Objectives: To determine the effect of NAC 600mg twice daily on angina frequency in patients with ANOCA who experience angina at least 3 times/week as assessed by an angina diary.
Secondary Objective: The secondary objectives of this study are:
- To assess the impact of NAC therapy (600mg twice daily) on quality of life/health status, utilising generic (EQ-5D) and disease-specific (SAQ-7) health status instruments to evaluate the following PROMs:
- Overall physical health (EQ-5D)
- Angina frequency (SAQ-7)
- angina-related physical limitations (SAQ-7)
- angina-related quality of life (SAQ-7)
- patient satisfaction with angina therapy (SAQ-7) ii. To assess the impact of NAC therapy (600mg twice daily) on angina diary measures including:
- Short-acting nitrate consumption (i.e., Glyceryl trinitrate (GTN) spray use) b) Duration of angina episodes c) Severity of angina episodes
Safety objectives i. Emergency Department (ED) presentations with Chest pain ii. Hospital admissions with chest pain iii. Major Adverse Coronary Events (MACE) Clinic Assessments: Visit 1: Screening: Screening assessments will be completed within 14 days prior to administration of NAC/Placebo.
- Consent to participate
- Baseline safety bloods (complete blood examination, electrolytes, liver \& kidney functions tests, high sensitivity C-reactive protein, ionised calcium)
- Physical Examination
- Vital assessments
- Electrocardiogram (ECG) assessment Week 1 \& 2
- Angina Diary Visit 2: Weeks 3-6: Phase 1 study medication period
- Angina Diary
- Health-related questionnaires (SAQ-7, EQ-5D) Visit 3: End of Phase 1 visit
- Angina Diary
- Health-related questionnaires (SAQ-7, EQ-5D) Weeks 7\& 8 Wash out Period
- Angina Diary Visit 4: Weeks 9-12 Phase 2 study medication period
- Angina Diary
- Health-related questionnaires (SAQ-7, EQ-5D) Visit 5: End of Phase 2 visit
- Health-related questionnaires (SAQ-7, EQ-5D) Weeks 4,10 \& 14 Follow up Phone Contact Duration of Therapy: Patients 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 (double-blind, crossover design) giving a total dosing period of 8 weeks. There will be a 2-week (14 day) washout between the two treatment periods.
Criteria for Evaluation: Angina diary: Results will be considered significant if participants have significantly (p<0.05) reduced features of angina extracted from angina diary during the NAC phase compared to placebo phase.
SAQ-7: Results will be considered significant if participants demonstrate reduced physical limitations \& angina frequency and improved quality of life during NAC phase compared to placebo phase.
EQ-5D: Results will be considered significant if participants demonstrate improved quality of life scores during NAC Phase compared to placebo phase.
Statistical Methods: Efficacy Endpoint NAC's anti-anginal efficacy will be undertaken by blinded analysis of the angina diary endpoints and other endpoints. The comparison between patients with respect to treatment order will be analysed utilising a linear mixed-effects model.
Safety Endpoint Frequency and severity of adverse events.
- Being tested
- N-Acetylcysteine (NAC), Placebo
- Keywords
- ANOCA, Angina with Non Obstructive Coronary Arteries, N-acetylcysteine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetylcysteine (NAC)Drug
The 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
PlaceboDrug
To 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral NAC 600mg (twice daily) Intervention Arm | Experimental | This arm will assess the effects of oral N-Acetylcysteine (NAC) at a dose of 600mg twice daily in patients with ANOCA. Participants will receive the NAC treatment for a 4-week period. Receives: Drug: N-Acetylcysteine (NAC) |
| Placebo 600mg twice daily | Placebo comparator | This arm will serve as the placebo comparator in the crossover study design. Participants will receive a placebo treatment that is identical in appearance to the NAC medication but contains no active ingredient.The order of treatment (NAC vs placebo) is randomized and participants remain blinded throughout the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks (4 weeks of NAC treatment and 4 weeks of placebo treatment)
Secondary outcomes (8)
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
Measured: 8 weeks (4 weeks treatment compared to 4 weeks placebo)
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
Measured: 8 weeks (4 weeks of NAC treatment and 4 weeks of placebo treatment)
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.
Measured: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
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.
Measured: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Angina-related quality of life score as assessed on Seattle Angina Questionnaire
Patients assess the impact of angina on their overall quality of life, including emotional well-being, physical limitations, and social functioning. The score is converted to a 0-100 scale, with higher scores reflecting better quality of life and less impact from angina.
Measured: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Patient satisfaction with angina therapy score as assessed on Seattle Angina Questionnaire
Patients rate their satisfaction with the current treatment regimen for managing angina, based on structured questions related to the effectiveness, convenience, and side effects of therapy. The score is converted to a 0-100 scale, with higher scores indicating greater satisfaction.
Measured: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Overall physical health as assessed by EQ-5D Questionnaire
EQ-5D is a standardized questionnaire developed by the EuroQol Group to measure health-related quality of life.
Patients assess their overall physical health through the EQ-5D, which includes questions related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score is then converted to a 0-100 scale, with higher scores indicating better overall physical health and less impact from the condition.
Measured: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Severity score of angina episodes as assessed on angina diary
Angina severity score (scored as 1-10), 10 being most intense assessed from patient's self-reported angina diary
Measured: 8 weeks (4 weeks of NAC treatment and 4 weeks of placebo treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina AttacksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, double-blind, placebo-controlled crossover study assessing the anti-anginal effect and impact on health status of NAC 600mg twice daily in patients with ANOCA experiencing angina at least 3 times/week32
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sivabaskari Pasupathy, University of Adelaide
- Investigators
- John Beltrame, PhD, Principal investigator, University of AdelaideSivabaskari Pasupathy, PhD, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890507
- Sponsor's protocol ID
- 2025/HRE00080
- Acronym
- NANA
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The collected data contains confidential patient health information. De-identified data may be made available upon request, but it will not be publicly accessible due to the inclusion of confidential patient health information. Access will be granted in accordance with ethical guidelines and institutional policies, ensuring that all requests are reviewed and approved before data is shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anti-Anginal Effects of N-Acetylcysteine (NAC) in Patients with Angina and Non-Obstructive Coronary Arteries (ANOCA)
- ClinicalTrials.gov ID
- NCT06890507
- Acronym / sponsor ID
- NANA / 2025/HRE00080
- Keywords
- ANOCA, Angina with Non Obstructive Coronary Arteries, N-acetylcysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Angina with Non-Obstructive Coronary Arteries (ANOCA) refers to a condition where patients experience chronic angina despite having no significant coronary artery blockages. This condition affects 50-70% of women undergoing elective angiography, in stark contrast to just 7-17% of men. Many experience a prolonged delay in diagnosis, resulting in notable decreases in functional capacity.
NAC has been shown to reduce oxidative stress and potentiate the vasodilatory and antiaggregatory effects of nitrates, potentially reducing microvascular damage and improving myocardial perfusion, hence presenting a promising therapeutic option for ANOCA patients. Although there are no established clinical guidelines for ANOCA management, standard therapy typically includes both long-acting and short-acting nitrates to alleviate anginal symptoms. However, many ANOCA patients continue to experience symptoms despite standard therapy. As such, this trial will assess the beneficial effects of NAC therapy in ANOCA women.
Primary Objectives: To determine the effect of NAC 600mg twice daily on angina frequency in patients with ANOCA who experience angina at least 3 times/week as assessed by an angina diary.
Secondary Objective: The secondary objectives of this study are:
- To assess the impact of NAC therapy (600mg twice daily) on quality of life/health status, utilising generic (EQ-5D) and disease-specific (SAQ-7) health status instruments to evaluate the following PROMs:
- Overall physical health (EQ-5D)
- Angina frequency (SAQ-7)
- angina-related physical limitations (SAQ-7)
- angina-related quality of life (SAQ-7)
- patient satisfaction with angina therapy (SAQ-7) ii. To assess the impact of NAC therapy (600mg twice daily) on angina diary measures including:
- Short-acting nitrate consumption (i.e., Glyceryl trinitrate (GTN) spray use) b) Duration of angina episodes c) Severity of angina episodes
Safety objectives i. Emergency Department (ED) presentations with Chest pain ii. Hospital admissions with chest pain iii. Major Adverse Coronary Events (MACE) Clinic Assessments: Visit 1: Screening: Screening assessments will be completed within 14 days prior to administration of NAC/Placebo.
- Consent to participate
- Baseline safety bloods (complete blood examination, electrolytes, liver \& kidney functions tests, high sensitivity C-reactive protein, ionised calcium)
- Physical Examination
- Vital assessments
- Electrocardiogram (ECG) assessment Week 1 \& 2
- Angina Diary Visit 2: Weeks 3-6: Phase 1 study medication period
- Angina Diary
- Health-related questionnaires (SAQ-7, EQ-5D) Visit 3: End of Phase 1 visit
- Angina Diary
- Health-related questionnaires (SAQ-7, EQ-5D) Weeks 7\& 8 Wash out Period
- Angina Diary Visit 4: Weeks 9-12 Phase 2 study medication period
- Angina Diary
- Health-related questionnaires (SAQ-7, EQ-5D) Visit 5: End of Phase 2 visit
- Health-related questionnaires (SAQ-7, EQ-5D) Weeks 4,10 \& 14 Follow up Phone Contact Duration of Therapy: Patients 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 (double-blind, crossover design) giving a total dosing period of 8 weeks. There will be a 2-week (14 day) washout between the two treatment periods.
Criteria for Evaluation: Angina diary: Results will be considered significant if participants have significantly (p<0.05) reduced features of angina extracted from angina diary during the NAC phase compared to placebo phase.
SAQ-7: Results will be considered significant if participants demonstrate reduced physical limitations \& angina frequency and improved quality of life during NAC phase compared to placebo phase.
EQ-5D: Results will be considered significant if participants demonstrate improved quality of life scores during NAC Phase compared to placebo phase.
Statistical Methods: Efficacy Endpoint NAC's anti-anginal efficacy will be undertaken by blinded analysis of the angina diary endpoints and other endpoints. The comparison between patients with respect to treatment order will be analysed utilising a linear mixed-effects model.
Safety Endpoint Frequency and severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blind, placebo-controlled crossover study assessing the anti-anginal effect and impact on health status of NAC 600mg twice daily in patients with ANOCA experiencing angina at least 3 times/week32
| Arm | Type | Receives |
|---|---|---|
| Oral NAC 600mg (twice daily) Intervention Arm | Experimental | Drug: N-Acetylcysteine (NAC)This arm will assess the effects of oral N-Acetylcysteine (NAC) at a dose of 600mg twice daily in patients with ANOCA. Participants will receive the NAC treatment for a 4-week period. |
| Placebo 600mg twice daily | Placebo comparator | Drug: PlaceboThis arm will serve as the placebo comparator in the crossover study design. Participants will receive a placebo treatment that is identical in appearance to the NAC medication but contains no active ingredient.The order of treatment (NAC vs placebo) is randomized and participants remain blinded throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
- Secondary causes of angina including:
- clinically significant anaemia (haemoglobin <100g/dL) ii. uncontrolled atrial fibrillation (ventricular response rate >108bpm) iii. haemodynamically significant aortic stenosis (mean valve gradient ≥40mmHg) d) Known concomitant disease with life expectance of less than 1 year. e) Abnormalities in liver function tests suggesting hepatic impairment (ALT and/or AST 2 x upper limit of normal (ULN) or ALP 2 x ULN or Bilirubin 1.5 x ULN) f) Severe renal impairment (eGFR <30mL/min) or on dialysis. g) Pregnancy or lactation. h) Untreated hypertension i) Unwilling, or unable, to give informed consent, including due to severe psychiatric conditions affecting informed consent process or compliance.
- History of substance abuse. k) Currently taking Chloroquine. l) Serious or unstable medical conditions that may interfere with the study, as determined by the PI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetylcysteine (NAC)The 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 | Drug | Oral NAC 600mg (twice daily) Intervention Arm |
| PlaceboTo 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. | Drug | Placebo 600mg twice daily |
Primary outcome
Frequency of angina episodes recorded in angina diary.
Time frame: 8 weeks (4 weeks of NAC treatment and 4 weeks of placebo treatment)
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.
8 secondary outcomes
Frequency of Short-acting nitrate consumption (i.e., Glyceryl trinitrate (GTN) spray use)
Time frame: 8 weeks (4 weeks treatment compared to 4 weeks placebo)
Frequency of prolonged angina episodes (ie episodes persisting > 20 minutes)
Time frame: 8 weeks (4 weeks of NAC treatment and 4 weeks of placebo treatment)
Angina frequency score as assessed by Seattle Angina Questionnaire (SAQ)
Time frame: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Angina-related physical limitations score as assessed on Seattle Angina Questionnaire
Time frame: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Angina-related quality of life score as assessed on Seattle Angina Questionnaire
Time frame: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Patient satisfaction with angina therapy score as assessed on Seattle Angina Questionnaire
Time frame: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Overall physical health as assessed by EQ-5D Questionnaire
Time frame: End of Phase 1 (Score at the end of 4 weeks) & End of Phase 2 ( Score at the end of 4 weeks)
Severity score of angina episodes as assessed on angina diary
Time frame: 8 weeks (4 weeks of NAC treatment and 4 weeks of placebo treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No. The collected data contains confidential patient health information. De-identified data may be made available upon request, but it will not be publicly accessible due to the inclusion of confidential patient health information. Access will be granted in accordance with ethical guidelines and institutional policies, ensuring that all requests are reviewed and approved before data is shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Beltrame, PhD principal investigator
University of Adelaide
Sivabaskari Pasupathy, PhD principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Acetylcysteine (NAC) in people with Angina Attacks and Non Obstructive Coronary Artery Disease, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sivabaskari Pasupathy, PhD (+6182228685, sivabaskari.pasupathy@adelaide.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of angina episodes recorded in angina diary. (time frame: 8 weeks (4 weeks of NAC treatment and 4 weeks of placebo treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.