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Allopurinol in Acute Coronary Syndrome (ALLACS)

Primary Purpose

Chronic Stable Angina

Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Allopurinol
Allopurinol
Placebo
Sponsored by
Stephen McSwiggan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina focused on measuring Allopurinol, Angina, Acute coronary syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NHS Tayside

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Allopurinol High dose

Allopurinol Low dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
angina pain and Glyceryl TriNitrate (GTN) usage
subjects will use angina log to record symptoms of angina and GTN usage between hospital visits

Full Information

First Posted
October 17, 2011
Last Updated
May 26, 2015
Sponsor
Stephen McSwiggan
Collaborators
British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01457820
Brief Title
Allopurinol in Acute Coronary Syndrome
Acronym
ALLACS
Official Title
Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment: stopped early
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen McSwiggan
Collaborators
British Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina
Keywords
Allopurinol, Angina, Acute coronary syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol High dose
Arm Type
Experimental
Arm Title
Allopurinol Low dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Stat dose Allopurinol 800mg, then 400mg BD for 5 days
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Stat dose Allopurinol 400mg, then 300mg BD for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo, stat dose, then 5 days of matched placebo BD.
Primary Outcome Measure Information:
Title
Change in time to exercise induced ST depression
Description
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.
Time Frame
4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
Secondary Outcome Measure Information:
Title
change in total exercise time on Exercise Tolerance Testing (ETT)
Description
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.
Time Frame
4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
Title
Change in time to subjects reported symptoms of chest pain during exercise testing.
Description
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.
Time Frame
hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
Title
changes in blood markers, specifically Brain Naturetic Peptide (BNP), high sensitivity Troponin T and high sensitivity C Reactive Protein (hsCRP), during exercise testing
Description
Baseline is pre 1st study drug dose exercise tolerance test (ETT). Comparisons will be made before and after 4 hour post drug ETT
Time Frame
Pre and post 4 hour ETT compared to baseline
Title
angina pain and Glyceryl TriNitrate (GTN) usage
Description
subjects will use angina log to record symptoms of angina and GTN usage between hospital visits
Time Frame
Weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Tayside
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

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Allopurinol in Acute Coronary Syndrome

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