Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in time to exercise induced ST depression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Allopurinol Low dose
干预措施: Allopurinol (Drug)
Allopurinol High dose
干预措施: Allopurinol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in time to exercise induced ST depression
时间窗: 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
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.
次要结局
- changes in blood markers, specifically Brain Naturetic Peptide (BNP), high sensitivity Troponin T and high sensitivity C Reactive Protein (hsCRP), during exercise testing(Pre and post 4 hour ETT compared to baseline)
- angina pain and Glyceryl TriNitrate (GTN) usage(Weekly)
- change in total exercise time on Exercise Tolerance Testing (ETT)(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.(hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug)
研究者
Stephen McSwiggan
Senior Clinical Trials Manager
University of Dundee