<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02191670</url>
  </required_header>
  <id_info>
    <org_study_id>1123.22</org_study_id>
    <nct_id>NCT02191670</nct_id>
  </id_info>
  <brief_title>Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation</brief_title>
  <official_title>A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation.&#xD;
      Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue&#xD;
      plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction&#xD;
      in usual routine treatment after market launch&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2005</start_date>
  <primary_completion_date type="Actual">January 2006</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of serious adverse events (SAE)</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital rate of death</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital rate of stroke</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital rate of intracranial hemorrhage</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital rate of major bleeding</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital rate of non-fatal cardiac events</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>METALYSE®</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>METALYSE®</intervention_name>
    <description>weight-adjusted dosage as single bolus over 5 to 10 seconds</description>
    <arm_group_label>METALYSE®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  onset of symptoms of AMI within 6 hours&#xD;
&#xD;
          -  on a twelve-lead electrocardiogram (ECG), ST-segment elevation ≥ 0.1 millivolt (mV) in&#xD;
             two or more limb leads, or &gt; 0.2 mV in two or more contiguous precordial leads&#xD;
             indicative of AMI, or left bundle-branch block&#xD;
&#xD;
          -  age ≥ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant bleeding disorder at present or within the past 6 months, known&#xD;
             hemorrhagic diathesis&#xD;
&#xD;
          -  patients with current concomitant oral anticoagulant therapy with International&#xD;
             Normalised Ratio (INR) &gt; 1.3&#xD;
&#xD;
          -  any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or&#xD;
             spinal surgery)&#xD;
&#xD;
          -  severe uncontrolled arterial hypertension (hypertension defined as blood pressure&#xD;
             180/110 mm Hg (systolic BP &gt; 180 mm Hg and/or diastolic BP &gt; 100 mm Hg) on one single&#xD;
             reliable measurement during current admission prior to study enrolment&#xD;
&#xD;
          -  major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2&#xD;
             months (this includes any trauma associated with the current AMI), recent trauma to&#xD;
             the head or cranium&#xD;
&#xD;
          -  prolonged or traumatic cardiopulmonary resuscitation (&gt; 2 minutes) within the past 2&#xD;
             weeks&#xD;
&#xD;
          -  severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension&#xD;
             (esophageal varices) and active hepatitis&#xD;
&#xD;
          -  diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions&#xD;
&#xD;
          -  active peptic ulceration&#xD;
&#xD;
          -  arterial aneurysm and known arterial/venous malformation&#xD;
&#xD;
          -  neoplasm with increased bleeding risk&#xD;
&#xD;
          -  Acute pericarditis and/or subacute bacterial endocarditis&#xD;
&#xD;
          -  Acute pancreatitis&#xD;
&#xD;
          -  hypersensitivity to the active substance tenecteplase and to any of the excipients&#xD;
&#xD;
          -  use of Abciximab (ReoPro®) or other marketed GPIIb/IIIa antagonists within the&#xD;
             preceding 12 hours&#xD;
&#xD;
          -  any minor head trauma and any other trauma occurring after onset of the current&#xD;
             myocardial infarction&#xD;
&#xD;
          -  any known history of stroke or transient ischemic attack or dementia&#xD;
&#xD;
          -  pregnancy or lactation, parturition within the previous 30 days. Women of childbearing&#xD;
             potential must have a negative pregnancy test&#xD;
&#xD;
          -  any known active participation in another investigative drug study or device protocol&#xD;
             in the past 30 days&#xD;
&#xD;
          -  previous enrollment in this study&#xD;
&#xD;
          -  inability to follow protocol and comply with follow-up requirements&#xD;
&#xD;
          -  any other condition that the investigator feels would place the patient at increased&#xD;
             risk if the investigational therapy is initiated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.22_U08-1264-02.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenecteplase</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02191670
org study id: 1123.22
nct id: NCT02191670
lead sponsor: 
Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation.
      Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue
      plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction
      in usual routine treatment after market launch
observational model: Cohort
time perspective: Prospective
measure: Number of serious adverse events (SAE)
time frame: up to 30 days
measure: In-hospital rate of death
time frame: up to 30 days
measure: In-hospital rate of stroke
time frame: up to 30 days
measure: In-hospital rate of intracranial hemorrhage
time frame: up to 30 days
measure: In-hospital rate of major bleeding
time frame: up to 30 days
measure: In-hospital rate of non-fatal cardiac events
time frame: up to 30 days
measure: Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke
time frame: up to 30 days
arm group label: METALYSE®
intervention type: Drug
intervention name: METALYSE®
description: weight-adjusted dosage as single bolus over 5 to 10 seconds
arm group label: METALYSE®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.22_U08-1264-02.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Tenecteplase