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

Phase 4

Completed

• Conditions: Syndrome X
• Interventions: Drug: placebo; Drug: allopurinol

• Registration Number: NCT00512057
• Lead Sponsor: University of Dundee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Study Start: 2008-06
• Status Verified: 2009-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-25
• Last Update Posted: 2010-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	allopurinol	-

Primary Outcome Measures

Name	Time	Method
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	3-5 years

Secondary Outcome Measures

Name	Time	Method
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	3- 5years

Trial Locations

Locations (1)

University of Dundee; 🇬🇧 Dundee, United Kingdom