Official Title: “APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X”

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. We 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Drug: allopurinol
  • allopurinol 300mg twice a day
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: Yes

Inclusion Criteria:

• Typical history of angina
• Positive exercise treadmill test and normal coronary angiogram

Exclusion Criteria:

• Significant valvular heart disease or left ventricular hypertrophy
• Age <18 years

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Dundee

Overall Clinical Trial Officials and Contacts

Chim Lang Principal Investigator University of Dundee  

Overall Contact: tiong lim 01382632180 t.k.lim@dundee.ac.uk

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00512057

Study ID Number: apex001 version6

ClinicalTrials.gov Identifier: NCT00512057

Health Authority: United Kingdom: Research Ethics Committee