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| Tracking Information | |||||
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| First Received Date ICMJE | August 6, 2007 | ||||
| Last Updated Date | February 17, 2009 | ||||
| Start Date ICMJE | June 2008 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary objective of this study is to investigate the effects of allopurinol on coronary and peripheral microvascular and endothelial function in patients with cardiac syndrome X [ Time Frame: 3-5 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The primary objective of this study is to investigate the effects of allopurinol on coronary and peripheral microvascular and endothelial function in patients with cardiac syndrome X [ Time Frame: 3-5 years ] | ||||
| Change History | Complete list of historical versions of study NCT00512057 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The secondary objectives of this study are to assess the effects of allopurinol on chest pain incidence, maximal ST-segment depression and Duke's score [ Time Frame: 3- 5years ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
The secondary objectives of this study are to assess the effects of allopurinol on chest pain incidence, maximal ST-segment depression and Duke's score [ Time Frame: 3- 5years ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X | ||||
| Official Title ICMJE | APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X | ||||
| Brief Summary | Morbidity of patients with cardiac syndrome X (typical anginal-like chest pain and normal coronary arteriograms) is high with continuing episodes of chest pain and frequent hospital readmissions. Management of this syndrome represents a major challenge to the treating physician. Evidence for the important role of endothelial dysfunction and oxidative stress in the pathogenesis of cardiac syndrome X has been recently strengthened by the finding that basal superoxide production predicts future cardiovascular events in this patient group. The investigators have recently shown that high-dose allopurinol abolishes vascular oxidative stress and improves endothelial function in patients with chronic heart failure, which makes allopurinol a prime candidate to reduce oxidative stress in syndrome X. The hypothesis to be tested in this study is whether allopurinol offers dual benefits of improving vascular function and reducing myocardial ischaemia in patients with cardiac syndrome X. This study may discover a novel way to improve endothelial function and anginal symptoms which are often debilitating in these patients. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE | Syndrome X | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00512057 | ||||
| Responsible Party | Chim Lang, University of Dundee | ||||
| Study ID Numbers ICMJE | apex001 version6 | ||||
| Study Sponsor ICMJE | University of Dundee | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Dundee | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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