Status:
NOT_YET_RECRUITING
The Anti-Anginal Effects of N-Acetylcysteine (NAC) in Patients with Angina and Non-Obstructive Coronary Arteries (ANOCA)
Lead Sponsor:
University of Adelaide
Conditions:
Angina Attacks
Non Obstructive Coronary Artery Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 impac...
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 conditio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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:
- i. 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.
- j) 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.
- m) 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)
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06890507
Start Date
June 1 2025
End Date
September 1 2027
Last Update
March 24 2025
Active Locations (1)
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1
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011