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

• Sponsor: University of Dundee (Other)
• Overall Status: Completed
• CT.gov ID: NCT00512057
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Syndrome X	Drug: allopurinol; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2008
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

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

Outcome Measures

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 [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 [3- 5years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Dundee	Dundee		United Kingdom	dd1 3sy

Sponsors and Collaborators

• University of Dundee

Investigators

• Principal Investigator: Chim Lang, University of Dundee

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00512057
• Other Study ID Numbers: apex001 version6
• First Posted: Aug 7, 2007
• Last Update Posted: Jun 28, 2010
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: cardiac syndrome X; endothelial function
• Additional relevant MeSH terms: Microvascular Angina; Syndrome; Allopurinol

Study Results

No Results Posted as of Jun 28, 2010