Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT01457820
Status:
TERMINATED
Last Update Posted:
2015-05-27
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allopurinol in Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'slow recruitment: stopped early', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in time to exercise induced ST depression', 'timeFrame': '4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug', '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.'}], 'secondaryOutcomes': [{'measure': 'change in total exercise time on Exercise Tolerance Testing (ETT)', 'timeFrame': '4 hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug', '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.'}, {'measure': 'Change in time to subjects reported symptoms of chest pain during exercise testing.', 'timeFrame': 'hours, 1 day and 5 days post study drug testing compared to Baseline 1 hour pre study drug', '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.'}, {'measure': 'changes in blood markers, specifically Brain Naturetic Peptide (BNP), high sensitivity Troponin T and high sensitivity C Reactive Protein (hsCRP), during exercise testing', 'timeFrame': 'Pre and post 4 hour ETT compared to baseline', 'description': 'Baseline is pre 1st study drug dose exercise tolerance test (ETT). Comparisons will be made before and after 4 hour post drug ETT'}, {'measure': 'angina pain and Glyceryl TriNitrate (GTN) usage', 'timeFrame': 'Weekly', 'description': 'subjects will use angina log to record symptoms of angina and GTN usage between hospital visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allopurinol', 'Angina', 'Acute coronary syndrome'], 'conditions': ['Chronic Stable Angina']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* angiographically documented coronary artery disease,\n* a positive exercise tolerance test (ETT)\n* a history of symptoms of chronic, stable, effort-induced angina for ≥ 2 months.\n* All concomitant antianginal medication will be allowed and continued unchanged during the study.\n\nExclusion Criteria:\n\n* the inability to do an ETT due to back or leg problems,\n* myocardial infarction or acute coronary syndrome ≤ 2 months,\n* coronary revascularization (percutaneous or CABG) ≤ 6 months,\n* Left Ventricular Ejection Fraction \\<45%,\n* estimated GFR \\<60 ml/min or creatinine \\>180 mmol/ml,\n* significant valvular pathology,\n* already had gout or on allopurinol,\n* atrial arrhythmias or ECG abnormalities interfering with ST-segment interpretation,\n* previous ventricular arrhythmias on ETT,\n* severe hepatic disease\n* or on azathioprine, 6 mercaptopurine or warfarin.\n* Patients who have participated in any other clinical trial within the previous 30 days will be excluded.\n* Patients who are unable to give informed consent will also be excluded from this trial'}, 'identificationModule': {'nctId': 'NCT01457820', 'acronym': 'ALLACS', 'briefTitle': 'Allopurinol in Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps', 'orgStudyIdInfo': {'id': '2010CV30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allopurinol High dose', 'interventionNames': ['Drug: Allopurinol']}, {'type': 'EXPERIMENTAL', 'label': 'Allopurinol Low dose', 'interventionNames': ['Drug: Allopurinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Stat dose Allopurinol 800mg, then 400mg BD for 5 days', 'armGroupLabels': ['Allopurinol High dose']}, {'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Stat dose Allopurinol 400mg, then 300mg BD for 5 days', 'armGroupLabels': ['Allopurinol Low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo, stat dose, then 5 days of matched placebo BD.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Angus', 'country': 'United Kingdom', 'facility': 'NHS Tayside', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dundee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stephen McSwiggan', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Trials Manager', 'investigatorFullName': 'Stephen McSwiggan', 'investigatorAffiliation': 'University of Dundee'}}}}