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The Anti-Anginal Effects of N-Acetylcysteine (NAC) in Patients with Angina and Non-Obstructive Coronary Arteries (ANOCA)

NCT06890507 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-03-24

No results posted yet for this study

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. 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.

Conditions

  • Angina Attacks
  • Non Obstructive Coronary Artery Disease

Interventions

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

DRUG

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.

Sponsors & Collaborators

  • University of Adelaide

    lead OTHER

Principal Investigators

  • John Beltrame, PhD · University of Adelaide

  • Sivabaskari Pasupathy, PhD · University of Adelaide

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-04-01
Completion
2027-09-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06890507 on ClinicalTrials.gov