E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
a Patients with ST-segment elevation AMI treated within 6 hours of symptom-onset. b Patients with chronic stable angina refractory to medical therapy who are not candidates for surgical or percutaneous coronary revascularisation. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
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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 |
The primary aim of the study is to compare the effects of erythropoietin EPO versus placebo on myocardial function and possible adverse drug-related events. |
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E.2.2 | Secondary objectives of the trial |
The secondary aim of the study is to compare the effects of EPO versus placebo on a left ventricular remodelling in patients with AMI, and on b myocardial perfusion in patients with chronic stable angina. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria for patients with AMI - continuous chest pain lasting 30 minutes but 6 hours; - 1mm ST-segment elevation on 2 ECG leads or new left bundle branch block; - planned treatment by primary percutaneous coronary angioplasty; - age 75 years; - signed informed consent. Inclusion criteria for patients with CSA - significant coronary artery disease at angiography; - maximal drug therapy; - inducible ischaemia on exercise testing; - no indication to undergo percutaneous or surgical coronary revascularisation; - age 75 years; - signed informed consent. |
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E.4 | Principal exclusion criteria |
Exclusion criteria for patients with AMI - previous myocardial infarction; - previous thrombolysis or treatment with EPO; - previous cerebrovascular event; - uncontrolled hypertension; - hematocrit 48 in men and 45 in women; - haemoglobin 16 g/dl in men and 15 g/dl in women; - major surgery, major trauma or blood transfusions in the previous 6 weeks; - current oral anticoagulant therapy; - allergy to aspirin; - renal, lung or liver failure; - myeloproliferative diseases or malignancies; - possible or known pregnancy; - participation in other clinical randomised trial; - pacemaker in situ. Exclusion criteria for patients with CSA - previous treatment with EPO; - previous cerebrovascular event; - uncontrolled hypertension; - hematocrit 48 in men and 45 in women; - haemoglobin 16 g/dl in men and 15 g/dl in women; - major surgery, major trauma or blood transfusions in the previous 6 weeks; - current oral anticoagulant therapy; - allergy to aspirin; - renal, lung or liver failure; - myeloproliferative diseases or malignancies; - possible or known pregnancy; - participation in other clinical randomised trial; - percutaneous or surgical coronary revascularisation in the previous 6 months; - pacemaker in situ. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess differences in infarct size for patients with AMI or in ischaemic threshold for patients with CSA between those randomized to receive EPO and those receiving placebo. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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 | |
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 |