Allopurinol in Acute Coronary Syndrome

Phase 4TerminatedNCT01457820

Stephen McSwiggan26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Stable Angina

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in time to exercise induced ST depression

A continuous ECG tracing will be recorded. Time to \>1mm change in ST measurements will be noted. Exercise Tolerance testing (ETT) 1 hour before study drug administration is baseline measurement. Comparisons will be made 4 hours, 1 day and 5 days after baseline ETT.

Time frame: 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug

Secondary Outcomes

change in total exercise time on Exercise Tolerance Testing (ETT)

A continuous ECG tracing will be recorded. Time to total exercise time, ie when patient can walk no further will be noted. Exercise Tolerance Testing (ETT) 1 hour before study drug administration is baseline measurement. Comparisons will be made 4 hours, 1 day and 5 days after baseline ETT.

Time frame: 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug

Change in time to subjects reported symptoms of chest pain during exercise testing.

A continuous ECG tracing will be recorded. Time to reported chest pain will be noted. Exercise Tolerance testing (ETT) 1 hour before study drug administration is baseline measurement. Comparisons will be made 4 hours, 1 day and 5 days after baseline ETT.

Time frame: hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug

changes in blood markers, specifically Brain Naturetic Peptide (BNP), high sensitivity Troponin T and high sensitivity C Reactive Protein (hsCRP), during exercise testing

Baseline is pre 1st study drug dose exercise tolerance test (ETT). Comparisons will be made before and after 4 hour post drug ETT

Time frame: Pre and post 4 hour ETT compared to baseline

angina pain and Glyceryl TriNitrate (GTN) usage

subjects will use angina log to record symptoms of angina and GTN usage between hospital visits

Time frame: Weekly