Chronic Stable AnginaPhase 4ALLACSNCT01457820
Allopurinol in Acute Coronary Syndrome
A Phase 4 study testing Allopurinol in people with Chronic Stable Angina, run by Stephen McSwiggan at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps
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
- Being tested
- Allopurinol, Placebo
- Keywords
- Allopurinol, Angina, Acute coronary syndrome
- Medical subject headings
- Angina, Stable, Angina Pectoris, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Stat dose Allopurinol 800mg, then 400mg BD for 5 days
AllopurinolDrug
Stat dose Allopurinol 400mg, then 300mg BD for 5 days
PlaceboDrug
Matched placebo, stat dose, then 5 days of matched placebo BD.
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol High dose | Experimental | Not described Receives: Drug: Allopurinol |
| Allopurinol Low dose | Experimental | Not described Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
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.
Measured: 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
Baseline is pre 1st study drug dose exercise tolerance test (ETT). Comparisons will be made before and after 4 hour post drug ETT
Measured: Pre and post 4 hour ETT compared to baseline
angina pain and Glyceryl TriNitrate (GTN) usage
subjects will use angina log to record symptoms of angina and GTN usage between hospital visits
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: slow recruitment: stopped early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen McSwiggan
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor-investigator, Stephen McSwiggan, University of Dundee
- Investigators
- Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457820
- Sponsor's protocol ID
- 2010CV30
- Acronym
- ALLACS
- Status last verified
- May 2015
- First submitted
- 17 Oct 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps
- ClinicalTrials.gov ID
- NCT01457820
- Acronym / sponsor ID
- ALLACS / 2010CV30
- Conditions
- Chronic Stable Angina
- Keywords
- Allopurinol, Angina, Acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment: stopped early
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Stephen McSwigganUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allopurinol High dose | Experimental | Drug: Allopurinol |
| Allopurinol Low dose | Experimental | Drug: Allopurinol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolStat dose Allopurinol 800mg, then 400mg BD for 5 days | Drug | Allopurinol High dose |
| AllopurinolStat dose Allopurinol 400mg, then 300mg BD for 5 days | Drug | Allopurinol Low dose |
| PlaceboMatched placebo, stat dose, then 5 days of matched placebo BD. | Drug | Placebo |
Primary outcome
Change in time to exercise induced ST depression
Time frame: 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug
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 secondary outcomes
change in total exercise time on Exercise Tolerance Testing (ETT)
Time frame: 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.
Time frame: 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
Time frame: Pre and post 4 hour ETT compared to baseline
angina pain and Glyceryl TriNitrate (GTN) usage
Time frame: Weekly
Results and safety
The study was stopped early (reason given: slow recruitment: stopped early). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Chronic Stable Angina, run by Stephen McSwiggan at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow recruitment: stopped early). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to exercise induced ST depression (time frame: 4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.