Allopurinol in Acute Coronary Syndrome

NCT ID: NCT01457820

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Chronic Stable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Allopurinol High dose

Group Type: EXPERIMENTAL

Allopurinol

Intervention Type: DRUG

Stat dose Allopurinol 800mg, then 400mg BD for 5 days

Allopurinol Low dose

Group Type: EXPERIMENTAL

Allopurinol

Intervention Type: DRUG

Stat dose Allopurinol 400mg, then 300mg BD for 5 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo, stat dose, then 5 days of matched placebo BD.

Interventions

Allopurinol

Stat dose Allopurinol 800mg, then 400mg BD for 5 days

Intervention Type: DRUG

Allopurinol

Stat dose Allopurinol 400mg, then 300mg BD for 5 days

Intervention Type: DRUG

Placebo

Matched placebo, stat dose, then 5 days of matched placebo BD.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

Stephen McSwiggan

OTHER

Sponsor Role: lead

Responsible Party

Stephen McSwiggan

Senior Clinical Trials Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

NHS Tayside

Dundee, Angus, United Kingdom

Countries

United Kingdom

Other Identifiers

2010CV30

Identifier Type: -

Identifier Source: org_study_id