E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ischaemic stroke or transient ischaemic attack (TIA) (ICD Classification Code I63.0-9 and G45.0-1). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061256 |
E.1.2 | Term | Ischaemic stroke |
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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 |
To establish whether allopurinol 300 mg given to a post stroke population leads to; 1. A trend toward a reduction in rate of carotid intima-media thickness progression rate (this a measure of the thickness of the arterial wall which links with cardiovascular risk). 2. An adverse side effect profile. 3. Changes in levels of circulating markers of endothelial function and levels of endothelial repair cells? |
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E.2.2 | Secondary objectives of the trial |
Is a large scale therapeutic trial of the effect of allopurinol on IMT post stroke required and feasible? (Our data will inform power and sample size calculations for the larger trial). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Ischaemic Stroke (including transient ischaemic attack (TIA) where symptoms last less than 24 hours). 2. Brain imaging not suggestive of an alternative diagnosis. 3. Randomisation within one year of ictus.
Ischaemic stroke will be defined as suggestive clinical features which can be classified according to the Oxfordshire Community Stroke Project classification and have a presumed vascular occlusive cause.
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E.4 | Principal exclusion criteria |
1. >70% extra-cranial internal carotid artery stenosis. 2. Significant co-morbidity or frailty likely to cause death within 12 months or likely to make adherence to study protocol difficult for participant. 3. Contra-indication to or indication for administration of allopurinol (as detailed in SmPC). 4. Concurrent azathioprine or 6-mercaptopurine therapy, other cytotoxic therapies, cyclosporine and didanosine. 5. Significant hepatic impairment as defined by serum bilirubin, AST or ALT greater than three times upper limit of normal. 6. eGFR < 50 mls/min. 7. Cognitive impairment deemed sufficient to compromise capacity to consent or to comply with the protocol. 8. Women of childbearing potential (defined as pre-menopausal and not having undergone hysterectomy). 9. Prisoners.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in carotid intima-media thickness (IMT) over a one year period (IMT progression rate). |
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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 | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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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It is defined as 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 | 3 |
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 | 0 |
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 |