STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction

• All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Cardiogenic shock [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Congestive heart failure (CHF) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Recurrent MI (reinfarction) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Rehospitalisation for cardiac reasons [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Rehospitalisation for non cardiac reasons [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Ischaemic stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Intracranial haemorrhage [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Non intracranial bleeds [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Serious clinical events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

• Death and shock and CHF and reinfarction and disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• ECG and enzyme changes [ Time Frame: at or before discharge ] [ Designated as safety issue: No ]
• Total stroke (fatal, disabling, non-disabling) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Death and shock [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Death and shock and CHF [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Death and shock and reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Death and shock and CHF and reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Death and non-fatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early 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) in Group A will be compared to primary PCI performed according to local standards in Group B.

The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.

• Procedure: primary PCI
  Standard primary PCI
• Drug: enoxaparin
  Adjunctive treatment
• Procedure: catheterisation
  Routine or rescue coronary intervention
• Drug: tenecteplase
  Single, weight-adjusted i.v. bolus of tenecteplase
• Drug: clopidogrel
  Adjunctive treatment

• Experimental: Tenecteplase
  Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
  Interventions:

  • Drug: enoxaparin
  • Procedure: catheterisation
  • Drug: tenecteplase
  • Drug: clopidogrel
• primary PCI
  Standard primary PCI
  Intervention: Procedure: primary PCI

• Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.
• Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1.

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

4.Informed consent received

Exclusion criteria:

Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint