E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST-segment elevation myocardial infarction (STEMI) |
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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 |
To investigate whether intracoronary bolus administration of abciximab during primary percutaneous coronary intervention is superior to intravenous bolus administration in improving myocardial perfusion in patients with STEMI. |
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E.2.2 | Secondary objectives of the trial |
To assess the impact of abciximab on - Bleeding complications - Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow, myocardial blush grade and distal embolization on coronary angiography -Persistent residual ST-segment deviation 30 to 60 minutes after the procedure -Enzymatic infarct size -Quantitative Coronary Angiographic measurements of vessel and lesion -Mortality and Major Adverse Cardiac Events (MACE, a combined end point of target vessel revascularization, reinfarction, and cardiovascular mortality) at 30 days and 1 year.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- a diagnosis of STEMI defined by a. chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission b. time from onset of symptoms of less than 12 hours c. ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads - primary PCI performed - verbal followed by written informed consent
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E.4 | Principal exclusion criteria |
- rescue PCI after thrombolytic therapy - need for emergency coronary artery bypass grafting - presence of cardiogenic shock - known existence of a life-threatening disease with a life expectancy of less than 6 months - inability to provide informed consent - age below 18 years - contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensie or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is a 25% increase in the incidence of ST-segment resolution >70% in the group treated with IC administration of abciximab. |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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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Recruitment continues until 530 patients have been randomised. The end of the study is defined as the last patient’s last contact with the investigator or co-investigator for obtaining follow up. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |