Value through Innovation27 July 2016

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_DR 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

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.