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Allopurinol in Acute Coronary Syndrome (ALLACS)

S

Stephen McSwiggan

Status and phase

Terminated
Phase 4

Conditions

Chronic Stable Angina

Treatments

Drug: Placebo
Drug: Allopurinol

Study type

Interventional

Funder types

Other

Identifiers

NCT01457820
2010CV30

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

26 participants in 3 patient groups, including a placebo group

Allopurinol High dose
Experimental group
Treatment:
Drug: Allopurinol
Drug: Allopurinol
Allopurinol Low dose
Experimental group
Treatment:
Drug: Allopurinol
Drug: Allopurinol
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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