Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Allopurinol in Acute Coronary Syndrome (ALLACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01457820
Recruitment Status : Terminated (slow recruitment: stopped early)
First Posted : October 24, 2011
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
Stephen McSwiggan, University of Dundee

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.

Condition or disease Intervention/treatment Phase
Chronic Stable Angina Drug: Allopurinol Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Allopurinol as a Possible New Therapy for Acute Coronary Syndromes:The Next Steps
Study Start Date : April 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Allopurinol High dose Drug: Allopurinol
Stat dose Allopurinol 800mg, then 400mg BD for 5 days

Experimental: Allopurinol Low dose Drug: Allopurinol
Stat dose Allopurinol 400mg, then 300mg BD for 5 days

Placebo Comparator: Placebo Drug: Placebo
Matched placebo, stat dose, then 5 days of matched placebo BD.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    Baseline is pre 1st study drug dose exercise tolerance test (ETT). Comparisons will be made before and after 4 hour post drug ETT

  4. angina pain and Glyceryl TriNitrate (GTN) usage [ Time Frame: Weekly ]
    subjects will use angina log to record symptoms of angina and GTN usage between hospital visits



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457820


Locations
Layout table for location information
United Kingdom
NHS Tayside
Dundee, Angus, United Kingdom, DD1 9SY
Sponsors and Collaborators
Stephen McSwiggan
British Heart Foundation
Investigators
Layout table for investigator information
Principal Investigator: Allan Struthers, BSc, MD, FRCP, FRSE, FMedSci University of Dundee

Layout table for additonal information
Responsible Party: Stephen McSwiggan, Senior Clinical Trials Manager, University of Dundee
ClinicalTrials.gov Identifier: NCT01457820    
Other Study ID Numbers: 2010CV30
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Stephen McSwiggan, University of Dundee:
Allopurinol
Angina
Acute coronary syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs