ST-elevation myocardial infaction within 3 hours of onset of symptoms MedDRA version: 9.1 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction
Conditions
Interventions
Trade Name: Metalyse (10000 units)
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Plavix 75 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Trade Name
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age equal or greater than 18 years 2. Onset of symptoms /= 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Expected performance of PCI /= 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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Evaluate single and composite safety and efficicacy endpoints up to or before 30 days following randsomisation;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 | — |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Spain, United Kingdom
Outcome results
None listed