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APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
This study is currently recruiting participants.
Study NCT00512057   Information provided by University of Dundee
First Received: August 6, 2007   Last Updated: February 17, 2009   History of Changes

August 6, 2007
February 17, 2009
June 2008
June 2010   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00512057 on ClinicalTrials.gov Archive Site
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 ]
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 ]
 
APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
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. 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.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Syndrome X
  • Drug: allopurinol
  • Drug: placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
December 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact: tiong lim 01382632180 t.k.lim@dundee.ac.uk
United Kingdom
 
NCT00512057
Chim Lang, University of Dundee
apex001 version6
University of Dundee
 
Principal Investigator: Chim Lang University of Dundee
University of Dundee
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP