E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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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 objective of this study is to evaluate the effects of intravenous erythropoietin after reperfusion on the left ventricular ejection fraction at 4-6 months follow-up measured by magnetic resonance imaging (MRI) in patients with STEMI undergoing primary PCI. |
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E.2.2 | Secondary objectives of the trial |
Changes in left ventricular ejection fraction and infarct size from 5-7 days and 4-6 months after randomization measured by MRI. Changes in infarct size from 5-7 days to 4-6 months after randomization measured by SPECT Changes in angiographically determined left ventricular ejection fraction and hypokinetic chords from baseline to 4-6 months after randomization. Death, recurrent myocardial infarction, recurrent intervention in the infarct related artery in hospital, at 30 days and 6 months.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
REVIVAL-3 Sub-Study: Progenitor Cell Mobilization and Inflammatory and Hemostatic Biomarkers Date: 29.09.2006 Objectives: to determine progenitor cell mobilization by erythropoietin in patients with acute myocardial infarction undergoing PCI . To assess time course and prognostic value of different inflammatory and hemostatic biomarkers.
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E.3 | Principal inclusion criteria |
1. Patients with ST-segment elevation myocardial infarction < 24h from pain start 2. Successful PCI and left ventricular ejection fraction <50%. 3. Informed, written consent 4. In women with childbearing potential a pregnancy test is obligatory.
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E.4 | Principal exclusion criteria |
1. Age ≤ 18 years and > 80 years. 2. Cardiogenic shock. 3. Pericarditis. 4. Malignancies/other comorbid conditions conditions with life expectancy < 1 year. 5. Previous myocardial infarction. 6. Planned staged PCI or prior PCI within 30 days from index procedure 7. Uncontrolled hypertension >160/100mmHg unresponsive to therapy 8. Epilepsy. 9. Active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery < 1 month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; and patient’s refusal to blood transfusion. 10. Hematologic disorders such as essential thrombocytosis, megakaryoblastic leukemia, polycythemia vera 11. Relevant hematologic deviations: hemoglobin < 100 g/l or hemoglobin >160 g/l platelet count < 100 x 10^9 cells/l or platelet count > 600 x 10^9 cells/l. 12. Any contraindication to magnetic resonance imaging: electronically, magnetically, and mechanically activated implants such as cardiac pacemakers, automatic cardioverter defibrillators, joint prostheses, surgical/vascular clips, hearing aids, neurostimulators, infusion pumps, etc metallic splinters in the eye ferromagnetic haemostatic clips in the central nervous system cochlear implants lead wires or similar wires prosthetic heart valves, if dehiscence is suspected non-ferromagnetic stapedial implants; haemostatic clips 13. Glomerular filtration rate < 30 ml/min or serum creatinine >30 mg/l or dependence on renal dialysis. 14. Chronic liver disease with GOT > 5-fold over the normal range. 15. Allergy to erythropoietin / true anaphylaxis after prior exposure to contrast media 16. Phenylketonuria 17. Previous enrollment in this trial. 18. Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding. 19. Patient’s inability to fully cooperate with the study protocol. 20. Other contraindication according to the summary of product characteristics of recombinant human erythropoietin beta (NeoRecormon®).
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E.5 End points |
E.5.1 | Primary end point(s) |
Left ventricular ejection fraction measured by magnetic resonance imaging at 4-6 months after randomization. |
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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 | No |
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) | Yes |
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
| 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 | No |
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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Detailed information is given in the study protocol. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |