E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST-elevation myocardial infarction |
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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 | 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 |
To examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure |
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E.2.2 | Secondary objectives of the trial |
Key secondary endpoint(s) evaluating the efficacy of the trial therapy: ST-segment resolution 90 minute ECG; TIMI-flow post PCI; indirect infarct size by enzyme release; individual clinical endpoints |
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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 |
1 - Estimation of myocardial salvage by MRT
2 - Doppler (ultra)sonography for the determination of the number of HITS and thus the estimation of the therapy effect |
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E.3 | Principal inclusion criteria |
1) >= 18 years of age
2) ST-elevation myocardial infarction, characterized by:
a)Clinical symptoms: Angina pectoris < 12 hours and Persistent angina > 30 minutes
b) ECG-criteria in 12-lead ECG: ST-segment elevation > 1mm in ≥ 2 extremity leads and / or ST-segment elevation > 2mm in ≥ 2 adjacent precordial leads 3) written informed consent
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E.4 | Principal exclusion criteria |
1) Known drug hypersensitivity to Abciximab, other components of the trial medication or murine monoclonal antibodies 2) Known drug hypersensitivity to ASS or heparin 3) Active peptic ulcus ventriculi or duodeni 4) Major surgical interventions, lithotripsy, intracranial / intraspinal interventions or puncture of a not sufficiently compressible vessel less than eight weeks before start of trial 5) Intracranial tumors 6) Active internal bleeding 7) Cerebrovascular complications less than 2 years befor start of trial 8) Known coagulation defect or thrombocytopenia 9) Arteriovenous malformations or aneurysm 10) Severe liver or renal insufficiency (creatinin clearence < 30 ml/min) 11) Uncontrolled hypertension, hypertensive retinopathy 12) Vasculitis 13) Previous thrombolysis (less than 12 hrs ago) 14) Lacking compliance 15) Pregnant or nursing women 16) Fertile female patients (< 2 years post their last menstruation) without using appropriate contraception (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) during trial participation 17) Participation in another interventional trial
Additional exclusion criteria for the MRT substudy:
1) Severe claustrophobia 2) Hemodynamic instability 3) Pacemaker or internal cardioverter defibrillator (ICD) 4) Metallic cerebral or intracranial implants 5) Known frug hypersensitivity to Gadolinium |
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E.5 End points |
E.5.1 | Primary end point(s) |
Combined clinical endpoint at 90 days consisting of mortality, reinfarction, and new congestive heart failure. |
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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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Intravenous bolus versus intracoronary bolus administration |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 27 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |