E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST-elevation myocardial infaction within 3 hours of onset of symptoms |
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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 |
Evaluate in a proof of concept approach the outcome of pre-hospital patients presenting 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 with timely coronary intervention as appropriate (or by rescue coronary intervention if 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 efficicacy endpoints up to or before 30 days following randsomisation |
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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 |
Health-economic sub-study of the STREAM trial Draft version 2, 26 August 2007 A health-economic sub-study will be performed to assess the economic consequences of the treatment strategies being tested in the STREAM trial. |
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E.3 | Principal inclusion criteria |
1. Age equal or greater than 18 years 2. Onset of symptoms < 3 hours prior to randomisation 3. 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 4. Informed consent received |
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E.4 | Principal exclusion criteria |
1. Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours 2. Previous CABG 3. Left bundle branch block or ventricular pacing 4. Patients with cardiogenic shock - Killip Class 4 5. Patients with a body weight < 55 kg (known or estimated) 6. 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 7. Hospitalisation for cardiac reason within past 48 hours 8. 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 anticoagulation (warfarin or coumadin) 9. Active bleeding or known bleeding disorder/diathesis 10. 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) 11. 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) 12. Any known history of haemorrhagic stroke, ischaemic stroke or transient ischaemic attack (TIA), or stroke of unknown origin 13. Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks 14. Known acute pericarditis and/or subacute bacterial endocarditis 15. Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis 16. Chronic dialysis or known renal insufficiency 17. Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk 18. Arterial aneurysm and known arterial/venous malformation 19. 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 20. Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days 21. Known hypersensitivity to tenecteplase, alteplase, acetylsalicylic acid, clopidogrel, enoxaparin, or to any of the excipients or to the contrast media used in angiography 22. 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) |
The study has an exploratory design; the following observations are considered as endpoints for safety and/or efficacy:
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
Mixed (efficacy and safety) composite safety endpoints within 30 days: - Death and non-fatal stroke - Death and shock and CHF and reinfarction and 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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
primary PCI according to established local standards |
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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.8.5.1 | Number of sites anticipated in the EEA | 80 |
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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Last visit (day 30) of last subject |
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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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |