[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584527":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":37,"locations":45,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Adelaide","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: N-Acetylcysteine (NAC)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","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",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","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.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"John Beltrame, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Sivabaskari Pasupathy, PhD",[38,42],{"name":36,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+6182228685","sivabaskari.pasupathy@adelaide.edu.au",{"name":33,"role":39,"phone":43,"phoneExt":26,"email":44},"+6182226740","john.beltrame@adelaide.edu.au",[46],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":26},"The Queen Elizabeth Hospital","Adelaide","South Australia","5011","Australia","AU",{"type":54,"coordinates":55},"Point",[56,57],138.59863,-34.92866,{"lat":57,"lon":56},{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Sivabaskari Pasupathy","Post doctoral Research Fellow","100584527","phase-2-the-anti-anginal-effects-of-n-acetylcysteine-nac-in-patients-with-angina-and-non-obstructive-coronary-arteries-anoca-100584527",false,"NCT06890507","The Anti-Anginal Effects of N-Acetylcysteine (NAC) in Patients with Angina and Non-Obstructive Coronary Arteries (ANOCA)","NANA","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Female patients aged ≥18 years\n3. 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.\n4. Chest pain occurring ≥3 times\u002Fweek in the preceding two weeks.\n\nExclusion Criteria:\n\n1. Known allergy to NAC or its components.\n2. 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).\n3. Secondary causes of angina including:\n\ni. clinically significant anaemia (haemoglobin \\\u003C100g\u002FdL) 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\u002For AST 2 x upper limit of normal (ULN) or ALP 2 x ULN or Bilirubin 1.5 x ULN) f) Severe renal impairment (eGFR \\\u003C30mL\u002Fmin) 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.\n\nj) 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.\n\nm) 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)","FEMALE","18 Years",{"count":72,"type":73},25,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","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:\n\n(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?\n\nResearchers will compare NAC to a placebo in a randomized, double-blind, placebo-controlled crossover study to determine its effectiveness.\n\nParticipants 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.\n\nThe effectiveness of N-Acetylcysteine (NAC) will be assessed using the following measures:\n\nAngina Diary: Participants will record the frequency and severity of their angina episodes.\n\nSeattle Angina Questionnaire-7 (SAQ-7): Participants will complete this questionnaire to assess physical limitations, angina frequency, and quality of life.\n\nEuroQol 5-Dimension (EQ-5D) Questionnaire: Participants will rate their overall health and quality of life.",[79,80],"Angina Attacks","Non Obstructive Coronary Artery Disease",[82,83,84],"ANOCA","Angina with Non Obstructive Coronary Arteries","N-acetylcysteine","NOT_YET_RECRUITING","2025-03-16",{"date":88,"type":89},"2025-03-24","ACTUAL",{"date":91,"type":73},"2025-06-01",{"date":93,"type":73},"2027-09-01",{"name":5,"class":6},1]