Back to resultsAPEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X (APEX)
Primary Purpose
Syndrome X
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
allopurinol
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Syndrome X focused on measuring cardiac syndrome X, endothelial function
Eligibility 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
Sites / Locations
- University of Dundee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00512057
Brief Title
APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
Acronym
APEX
Official Title
APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syndrome X
Keywords
cardiac syndrome X, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
allopurinol
Intervention Description
allopurinol 300mg twice a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chim Lang
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Dundee
City
Dundee
ZIP/Postal Code
dd1 3sy
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
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