STREAM - STrategic Reperfusion Early After Myocardial InfarctionComparison of the efficacy and safety of a strategy of early fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention versus a strategy of standard primary PCI in patients with acute myocardial infarction within 3 hours of onset of symptoms - STREAM

Conditions: ST-elevation myocardial infaction within 3 hours of onset of symptoms
MedDRA version: 14.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders

Registration Number: EUCTR2007-001219-44-AT

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

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
>/= 2 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of >/=4 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

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