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

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ClinicalTrials.gov Identifier: NCT00512057
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : June 28, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Syndrome X Drug: allopurinol Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
Study Start Date : June 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: allopurinol
allopurinol 300mg twice a day
Placebo Comparator: 2 Drug: placebo
placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512057


Locations
United Kingdom
University of Dundee
Dundee, United Kingdom, dd1 3sy
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Chim Lang University of Dundee

Responsible Party: Chim Lang, University of Dundee
ClinicalTrials.gov Identifier: NCT00512057     History of Changes
Other Study ID Numbers: apex001 version6
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: February 2009

Keywords provided by University of Dundee:
cardiac syndrome X
endothelial function

Additional relevant MeSH terms:
Syndrome
Microvascular Angina
Disease
Pathologic Processes
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs