Allopurinol in Acute Coronary Syndrome
Information source: University of Dundee
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Stable Angina
Intervention: Allopurinol (Drug); Allopurinol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Stephen McSwiggan Official(s) and/or principal investigator(s):
Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci, Principal Investigator, Affiliation: University of Dundee
Overall contact:
Fiona Shearer, MBChB, MRCP, Phone: 01382 632180, Email: fshearer@nhs.net
Summary
Allopurinol is a drug commonly used to treat gout. However recent studies have shown it has
the potential to help improve oxygen supply to heart muscle. In this study the Investigators
aim to find out if allopurinol slows down the onset of angina symptoms, as seen by a doctor
on a tracing of the heart (ECG- electrocardiogram), for patients who have been diagnosed
with heart disease, when exercising on a treadmill. The Investigators are also are trying to
figure out the best dose of allopurinol to use and to see how quickly it begins working. To
do this the investigators will recruit patients with angina, exercise them on a treadmill
after giving different doses of allopurinol and see if there is an improvement in their time
to bring on angina symptoms and signs. Patients recruited to this trial will receive three
different treatment regimes over a six week period. Each treatment regime will last for one
week with a one week rest period between each regime. This will involve up to eleven visits
to Ninewells Medical School, Dundee for testing.
Clinical Details
Official title: Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in time to exercise induced ST depression
Secondary outcome: change in total exercise time on Exercise Tolerance Testing (ETT)Change in time to subjects reported symptoms of chest pain during exercise testing. changes in blood markers, specifically Brain Naturetic Peptide (BNP), high sensitivity Troponin T and high sensitivity C Reactive Protein (hsCRP), during exercise testing angina pain and Glyceryl TriNitrate (GTN) usage
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- angiographically documented coronary artery disease,
- a positive exercise tolerance test (ETT)
- a history of symptoms of chronic, stable, effort-induced angina for ≥ 2 months.
- All concomitant antianginal medication will be allowed and continued unchanged during
the study.
Exclusion Criteria:
- the inability to do an ETT due to back or leg problems,
- myocardial infarction or acute coronary syndrome ≤ 2 months,
- coronary revascularization (percutaneous or CABG) ≤ 6 months,
- Left Ventricular Ejection Fraction <45%,
- estimated GFR <60 ml/min or creatinine >180 mmol/ml,
- significant valvular pathology,
- already had gout or on allopurinol,
- atrial arrhythmias or ECG abnormalities interfering with ST-segment interpretation,
- previous ventricular arrhythmias on ETT,
- severe hepatic disease
- or on azathioprine, 6 mercaptopurine or warfarin.
- Patients who have participated in any other clinical trial within the previous 30
days will be excluded.
- Patients who are unable to give informed consent will also be excluded from this
trial
Locations and Contacts
Fiona Shearer, MBChB, MRCP, Phone: 01382 632180, Email: fshearer@nhs.net
NHS Tayside, Dundee, Angus DD1 9SY, United Kingdom; Recruiting
Stephen J McSwiggan, Bsc(Hons), RGN, Phone: 01382 740136, Email: s.j.mcswiggan@dundee.ac.uk
Allan D Struthers, BSc, MD, FRCP, FRSE, FMedSci, Principal Investigator
Fiona Shearer, MBChB, MRCP, Sub-Investigator
Additional Information
Starting date: April 2012
Last updated: April 30, 2012
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