Clinical trial NCT01457820: Allopurinol in Acute Coronary Syndrome
Official title: Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Stable Angina
Keywords: Allopurinol
Angina
Acute coronary syndrome
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2011-10-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in time to exercise induced ST depression
timeFrame: 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
Secondary outcomes:
measure: change in total exercise time on Exercise Tolerance Testing (ETT)
timeFrame: 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
measure: Change in time to subjects reported symptoms of chest pain during exercise testing.
timeFrame: hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
measure: changes in blood markers, specifically Brain Naturetic Peptide (BNP), high sensitivity Troponin T and high sensitivity C Reactive Protein (hsCRP), during exercise testing
timeFrame: Pre and post 4 hour ETT compared to baseline
measure: angina pain and Glyceryl TriNitrate (GTN) usage
timeFrame: Weekly
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: NHS Tayside
state: Angus
Study officials:
affiliation: University of Dundee
name: Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci
role: PRINCIPAL_INVESTIGATOR
References: