E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with cardiac syndrome X (typical anginal-like chest pain and normal coronary arteriograms) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess the effects of allopurinol on chest pain incidence, maximal ST-segment depression, Duke score and biochemical markers. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Coronary mircovascular function: Coronary flow reserve of the left anterior descending artery using doppler echocardiography. 2. Peripheral Microvascular function: Changes in microvascular skin blood flow using laser Doppler imaging. 3. Peripheral endothelial function: Flow-mediated vasodilation of brachial artery using duplex ulrasound imaging. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |