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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.
Verified by University of Dundee, February 2009
First Received: August 6, 2007   Last Updated: February 17, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512057

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

Locations
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            
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Chim Lang University of Dundee
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009