Allopurinol in Acute Coronary Syndrome

Chronic Stable Angina Clinical Trial

— ALLACS  

Official title:

Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01457820
• Other study ID #: 2010CV30
• Status: Terminated
• Phase: Phase 4
• First received: October 17, 2011
• Last updated: May 26, 2015
• Start date: April 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Chronic Stable Angina

Intervention

Drug:
• Allopurinol
Stat dose Allopurinol 800mg, then 400mg BD for 5 days
• Allopurinol
Stat dose Allopurinol 400mg, then 300mg BD for 5 days
• Placebo
Matched placebo, stat dose, then 5 days of matched placebo BD.

Locations

Country	Name	City	State
United Kingdom	NHS Tayside	Dundee	Angus

Sponsors (2)

Lead Sponsor	Collaborator
Stephen McSwiggan	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug	No
Secondary	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.	4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug	No
Secondary	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.	hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug	No
Secondary	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	Pre and post 4 hour ETT compared to baseline	No
Secondary	angina pain and Glyceryl TriNitrate (GTN) usage	subjects will use angina log to record symptoms of angina and GTN usage between hospital visits	Weekly	No