The APEX Trial: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients with Cardiac Syndrome X - APEX study

Conditions: Patients with cardiac syndrome X (typical anginal-like chest pain and normal coronary arteriograms)

Registration Number: EUCTR2007-002293-54-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Criteria of inclusion as patients with cardiac syndrome X are as follows:
1.Typical chest pain at rest and/or on effort; normal 12-lead ECG at rest
2.Ischaemia-like ECG changes during exercise stress test (horizontal or downsloping ST-segment depression >0.1 mV) and/or myocardial reversible perfusion abnormalities during exercise stress as assessed by Technetium-99m stress myocardial perfusion imaging.
3 Normal left and right ventricular function at rest as assessed by echocardiography; absence of valvular heart disease and myocardial hypertrophy, and
4.Normal coronary angiograms at visual analysis.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age<18 or elderly patients (aged >75 yrs);
2.Patients with a history of poorly controlled hypertension.
3.Patients with a history of hypersensitivity reaction as a result of allopurinol.
4.Renal dysfunction (serum creatinine > 160 mmol/L) or anaemia (haemoglobin <10 g/dl) or thrombocytopenia (platelet<100X109/L) or agranulocytosis (white blood cell count <4 X109/L)
5.Patients who are unable to exercise including patients that will be excluded for reasons of safety or potential effects on exercise performance.
6.Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic blood pressure >95 mmHg at rest or >105 mmHg with exercise will also be a reason for exclusion.
7.Patients with underlying disease likely to limit life span and/or increase risk of interventions will be excluded i.e., cancer; cardiovascular disease; uncontrolled hypertension: SBP>180 mmHg or DBP>110 mmHg, recent stroke, any severe chronic disease (including renal and hepatic disease).
8.Pregnancy and lactating women.
9.Patient on azathioprine therapy