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

NCT00512057 | Completed Phase 4 DMC

• 1 other identifier: apex001 version6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Syndrome X

Keywords

cardiac syndrome X; endothelial function

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

1

EXPERIMENTAL

Drug: allopurinol

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

allopurinol DRUG

allopurinol 300mg twice a day

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Typical history of angina
• Positive exercise treadmill test and normal coronary angiogram

You may not qualify if:

• Significant valvular heart disease or left ventricular hypertrophy
• Age \<18 years

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

University of Dundee

Dundee, Dundee, dd1 3sy, United Kingdom

Location

MeSH Terms

Conditions

Microvascular Angina

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chim Lang

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: June 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 28, 2010

Record last verified: 2009-02

Locations

GB (1)