Allopurinol in Acute Coronary Syndrome

NCT01457820 | Terminated Phase 4

• 1 other identifier: 2010CV30
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Allopurinol; Angina; Acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (3)

Allopurinol High dose

EXPERIMENTAL

Drug: Allopurinol

Allopurinol Low dose

EXPERIMENTAL

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Allopurinol DRUG

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

Allopurinol High dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephen McSwiggan: lead
• British Heart Foundation: collaborator

Study Sites (1)

NHS Tayside

Dundee, Angus, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris; Acute Coronary Syndrome

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

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

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Clinical Trials Manager

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 24, 2011
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

GB (1)