E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST elevation myocardial infarction within 3 hours of onset of symtoms |
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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 |
In patients with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of pre-hospital fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required will be compared to a strategy of primary PCI according to established local standards. |
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E.2.2 | Secondary objectives of the trial |
Evaluate single and composite safety and efficacy endpoints up to or before 30 days following randomisation |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Age equal or greater than 18 years -Onset of symptoms < 3 hours prior to randomisation -12-lead ECG indicative of an acute STEMI (ST-elevation will be measured from the J point; scale: 1 mm per 0.1 mV): >= 2 mm ST-elevation across 2 contiguous precordial leads (V1-V6) or leads I and aVL for a minimum combined total of >= 4 mm ST-elevation or >= 3 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of >= 6 mm ST-elevation -Informed consent received |
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E.4 | Principal exclusion criteria |
-Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours -Previous CABG -Left bundle branch block or ventricular pacing -Patients with cardiogenic shock (Killip Class 4) -Patients with a body weight < 55 kg (known or estimated) -Uncontrolled hypertension, defined as a single blood pressure measurement >= 180/110 mm Hg (systolic BP >= 180 mm Hg and/or diastolic BP >= 110 mm Hg) prior to randomisation -Hospitalisation for cardiac reason within past 48 hours -Recent administration of any i.v. or s.c. anticoagulation within 12 hours including unfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anti-coagulation (warfarin or coumadin) -Active bleeding or known bleeding disorder/diathesis -Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months) -Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction) -Any known history of haemorrhagic stroke, ischaemic stroke or transient ischaemic attack (TIA), or stroke of unknown origin -Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks -Known acute pericarditis and/or subacute bacterial endocarditis -Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis -Chronic dialysis or known renal insufficiency -Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk -Arterial aneurysm and known arterial/venous malformation -Pregnancy or lactation or parturition within the previous 30 days; women of childbearing potential must have a negative urine pregnancy test, or use a medically accepted method of birth control -Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days -Known hypersensitivity to tenecteplase, alteplase, acetylsalicylic acid, clopidogrel, enoxaparin, or to any of the excipients or to the contrast media used in angiography -Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated |
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E.5 End points |
E.5.1 | Primary end point(s) |
#Single efficacy endpoints within 30 days: -All cause mortality -Cardiogenic shock -Congestive heart failure -Recurrent myocardial infarction -Rehospitalisation for cardiac reasons -Rehospitalisation for non-cardiac reasons #Single efficacy endpoints at or before discharge: -ECG and marker enzyme changes (infarct size; aborted myocardial infarction) #Composite efficacy endpoints within 30 days: -Death and shock -Death and shock and CHF -Death and shock and reinfarction -Death and shock and CHF and reinfarction #Single safety endpoints within 30 days: -Ischaemic stroke -Intracranial haemorrhage -Non-intracranial bleeds (total, major, minor, and blood transfusions) -Serious clinical events (resuscitated ventricular fibrillation, repeat target vessel recanalisation) #Composite safety endpoints within 30 days: -Total stroke (fatal, disabling, non-disabling) -Disabling stroke |
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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 | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | 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 |
strategy of standard primary PCI |
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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.8.5 | The trial involves multiple Member States | Yes |
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 | 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 | 1 |