Clinical Study Results

• ACTILYSE ® - Myocardial Infarction

  Clinical Study Number	135.301
  Study Indication	Myocardial Infarction
  Product	ACTILYSE ®
  Generic Name	Alteplase
  Lab Code
  Clinical Phase	IV
  Study Title	A multicentre, feasibility study of pre-hospital treatment of acute myocardial infarction based on diagnosis by interpretation of remotely acquired ECG and thrombolysis with accelerated alteplase (Actilyse®). Pre-Hospital Alteplase Remote Advice Of Hospital (PHARAOH)
  Study Document	Trial synopsis 135.301 english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.12
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IIIb, IV
  Study Title	A phase IIIb - IV, randomised, open label trial evaluating the efficacy and safety of tenecteplase together with unfractionated heparin prior to early PCI as compared to standard primary PCI in patients with acute myocardial infarction.(ASSENT 4 PCI) (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)
  Study Document	Trial Statement 1123.12_CO english Trial synopsis 1123.12_CO english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.25
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IV
  Study Title	Post Marketing Surveillance to monitor the safety and efficacy of Metalyse® (Tenecteplase) in Korean patients with Acute Myocardial Infarction
  Study Document	Trial synopsis 1123.25_CO english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.22
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IV
  Study Title	A Post Registration Therapeutic Observational Study of Metalyse® in Patients with Acute Myocardial Infarction in the Russian Federation
  Study Document	Trial synopsis 1123.22_CO english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.28
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IIIb/V
  Study Title	STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison 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
  Study Document	Trial synopsis 1123.28 english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.5
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IIIb
  Study Title	An open-label, randomised, parallel-group comparison to investigate the procoagulant effect of tenecteplase (TNK-tPA), alteplase (rt-PA) and streptokinase (SK) administered to patients with AMI.
  Study Document	Trial synopsis 1123.5 english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.11
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IIIb/IV
  Study Title	A phase IIIb-IV, randomised, open label trial on efficacy and safety of 2 parallel groups: full dose tenecteplase combined with unfractionated heparin orenoxaparin in acute myocardial infarction in the prehospital setting (ASSENT 3Plus) ASSENT 3 Plus was a satellite study to ASSENT 3 (main study). ASSENT (ASsessment of the Safety and Efficacy of New Thrombolyticregimens)
  Study Document	Trial synopsis 1123.11_CO english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.10
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IIIb
  Study Title	A phase IIIb, randomised, open label trial with 3 parallel groups: fulldose TNK-tPA together with heparin sodium, full dose TNK-tPA together with enoxaparin, and half dose TNK-tPA together with abciximab and heparin sodium in patients with acute myocardial infarction: ASSENT 3 (Assessment of the Safety and Efficacy of a New Thrombolytic regimen).
  Study Document	Trial synopsis 1123.10_CO english

• METALYSE ® - Myocardial Infarction

  Clinical Study Number	1123.16
  Study Indication	Myocardial Infarction
  Product	METALYSE ®
  Generic Name	Tenecteplase
  Lab Code
  Clinical Phase	IV
  Study Title	Surveillance of patients with suspected acute myocardial infarction that  receive prehospital or early in hospital (emergency department) thrombolysis with Metalyse®.
  Study Document	Trial synopsis 1123.16 english