E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Randomized evaluation of enoxaparin versus unfractioned heparine (UFH) with GPIIb/IIIa inhibitors; 70-100IU without GPIIb/IIIa inhibitors) in patients showing an acute ST elevation myocardial Infarction (STEMI). All STEMIs will be treated by fibrinolysis followed by a percutaneous transluminal coronary intervention (PCI). |
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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 | 10064345 |
E.1.2 | Term | ST segment elevation 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 demonstrate that administration of enoxaparin, followed by early diagnostic angiography and primary intervention, provides superior clinical benefit when compared with the administration of UFH followed by early diagnostic angiography and primary intervention. Superior clinical benefit is measured, in subjects who present with suspected acute MI and STsegment elevation and are randomized within 24 hours of symptom onset, by the reduction of the composite of the following endpoints which occur within 30 days of randomization:
· All-cause mortality, or
· Complications of MI, defined as: Recurrent MI or ACS , refractory ischemia, resuscitated cardiac arrest and/or VF, urgent revascularization, stroke, peripheral or pulmonary embolism or
· Procedure failure defined as: stent thrombosis; B.O. use GpIIB/IIIa; Non-TIMI 3 flow after PCI; ST resolution < 50% after PCI, or
· Non-CABG major bleeding during hospitalization |
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E.2.2 | Secondary objectives of the trial |
· The main safety objective is: major bleeding during hospitalization
· The main secondary objective is the ischemic end-point of death, reinfarction, refractory ischemia and/or urgent revascularization
· The other secondary efficacy objectives are each individual ischemic endpoint of the primary objective as well as the composite ischemic end-point of death, complications of MI or procedure failure.
· The other secondary safety objective is the composite of major and minor bleeding during hospitalization |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Be at least 18 years of age.
2- Has experienced continuous ischemic (cardiac) symptoms for at least 20 minutes.
3- Has onset of symptoms of qualifying acute MI within the past 24 hours, and planned for primary PCI. Patients presenting between 12 and 24 hours of symptom onset should still have an indication for primary PCI, i.e. persistent ischemic symptom and/or persistent or recurrent ST elevation
4- Has an ECG indicative of an acute STEMI showing: • ≥ 2 mm ST elevation in 2 or more contiguous precordial ECG leads (anterior infarction); or • ≥ 1 mm ST elevation in 2 or more contiguous limb ECG leads (other infarction); or • New or presumably new left bundle branch block (LBBB)
5- Shock patients are eligible (but not patients with prolonged cardiac arrest)
6- Be willing to provide informed consent (informed consent may be provided by a legally authorized representative if the patient is not able to provide it).
7- Agree to comply with all protocol-specified procedures, including protocol-mandated follow-up |
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E.4 | Principal exclusion criteria |
1-Use of UFH or LMWH or any other anticoagulant agent (Vit K antagonists, fondaparinux, bivalirudin) within 48 hours prior to randomization
2-Thrombolytic therapy within the previous 48 hours
3-Known or suspected pregnancy in women of childbearing potential
4-History of hypersensitivity or contraindication to heparin or LMWH
5-Contraindication to primary PCI or any excessive bleeding risk (e.g. recent surgery also including punctions in the region of the spinal canal) or suspected active internal bleeding
6-Coexistent condition associated with a limited life expectancy at short term (e.g. advanced cancer)
7-Prolonged (> 10 minutes) cardiopulmonary resuscitation (CPR)
8-Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Reduction of risk after 30 days (death, complication of MI e.g. recurrent MI or ACS , refractory ischemia, urgent revascularization, resuscitated cardiac arrest, stroke, peripheral or pulmonary embolism, procedure failure, non-CABG major bleeding
- Comparative evaluation of enoxaparin and standard heparine under following criteria: ischemic end-point of death, reinfarction, refractory ischemia and/or urgent revascularization |
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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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 90 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |