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| Sponsor: | University of Dundee |
|---|---|
| Information provided by: | University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00512057 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Syndrome X |
Drug: allopurinol Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: allopurinol
allopurinol 300mg twice a day
|
| 2: Placebo Comparator |
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: tiong lim | 01382632180 | t.k.lim@dundee.ac.uk |
| United Kingdom | |
| University of Dundee | Recruiting |
| Dundee, United Kingdom, dd1 3sy | |
| Contact: Tiong K Lim, MBBS 01382 644972 t.k.lim@dundee.ac.uk | |
| Contact: Chim C Lang, MD 01382 644972 c.c.lang@dundee.ac.uk | |
| Principal Investigator: Chim C Lang, MD | |
| Principal Investigator: | Chim Lang | University of Dundee |
More Information
| Responsible Party: | University of Dundee ( Chim Lang ) |
| Study ID Numbers: | apex001 version6 |
| Study First Received: | August 6, 2007 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00512057 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
cardiac syndrome X endothelial function |
|
Antimetabolites Allopurinol Antioxidants Disease Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Angina Pectoris Vascular Diseases Enzyme Inhibitors |
Microvascular Angina Protective Agents Gout Suppressants Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Free Radical Scavengers Cardiovascular Diseases Antirheumatic Agents |