<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/NCT02229799</url>
  </required_header>
  <id_info>
    <org_study_id>135.315</org_study_id>
    <nct_id>NCT02229799</nct_id>
  </id_info>
  <brief_title>Protocol for Post Marketing Surveillance of Actilyse Vial</brief_title>
  <official_title>Protocol for Post Marketing Surveillance of Actilyse Vial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objectives of this study are to review the safety and efficacy of Actilyse Vial&#xD;
      (hereafter referred to as &quot;Actilyse&quot;) in post-marketing use for treatment of acute ischemic&#xD;
      stroke, through investigating followings;&#xD;
&#xD;
        1. Unknown adverse events (especially serious adverse events)&#xD;
&#xD;
        2. Frequency (Incidence) and trend of adverse events under the actual practice&#xD;
&#xD;
        3. Factors on the safety profile of Actilyse&#xD;
&#xD;
        4. Factors on the efficacy profile of Actilyse&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>February 2003</start_date>
  <primary_completion_date type="Actual">December 2004</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>Clinical effectiveness assessed by 30 days-mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant abnormal findings in physical examination</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">265</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Actilyse</intervention_name>
    <arm_group_label>Stroke patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with acute ischemic stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All in/out patients diagnosed as acute ischemic stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Actilyse should not be administered to patients with high risk as follows:&#xD;
&#xD;
               -  Significant bleeding disorder at present or within the past 6 months, known&#xD;
                  hemorrhagic diathesis&#xD;
&#xD;
               -  Patients receiving oral anticoagulants, e.g. warfarin sodium (INR &gt; 1.3)&#xD;
&#xD;
               -  Manifest bleeding or recent severe or dangerous bleeding&#xD;
&#xD;
               -  History or evidence or suspicion of intracranial hemorrhage including&#xD;
                  sub-arachnoid hemorrhage&#xD;
&#xD;
               -  Any history of central nervous system damage (i.e. neoplasm, aneurysm,&#xD;
                  intracranial or spinal surgery)&#xD;
&#xD;
               -  Hemorrhagic retinopathy (e.g. in diabetes, vision disturbances may indicate&#xD;
                  hemorrhagic retinopathy) or other hemorrhagic ophthalmic conditions&#xD;
&#xD;
               -  Prolonged or traumatic cardiopulmonary resuscitation (&gt; 2 minutes), obstetrical&#xD;
                  delivery, within the past 10 days, recent puncture of a non-compressible&#xD;
                  blood-vessel (e.g. subclavian or jugular vein puncture)&#xD;
&#xD;
               -  Severe uncontrolled arterial hypertension&#xD;
&#xD;
               -  Bacterial endocarditis or pericarditis&#xD;
&#xD;
               -  Acute pancreatitis&#xD;
&#xD;
               -  Documented ulcerative gastrointestinal disease within the past 3 months,&#xD;
                  oesophageal varices, arterial-aneurysms, or arterial/venous malformations&#xD;
&#xD;
               -  Neoplasm with increased bleeding risk&#xD;
&#xD;
               -  Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal&#xD;
                  hypertension (oesophageal varices) and active hepatitis&#xD;
&#xD;
               -  Hypersensitive to the active substance alteplase or to any of the excipients&#xD;
&#xD;
          2. In cases of acute myocardial infarction and acute pulmonary embolism, any history of&#xD;
             stroke should be contraindicated.&#xD;
&#xD;
          3. In case that Actilyse is administered to acute ischaemic stroke, the followings should&#xD;
             be contraindicated:&#xD;
&#xD;
               -  Symptoms of ischemic attack began more than 3 hours prior to infusion start or&#xD;
                  when time of symptom onset is unknown,&#xD;
&#xD;
               -  Symptoms of acute ischemic stroke that were either rapidly improving or only&#xD;
                  minor before start of infusion&#xD;
&#xD;
               -  Severe stroke as assessed clinically and/or by appropriate imaging techniques,&#xD;
&#xD;
               -  Seizure at onset of stroke&#xD;
&#xD;
               -  Evidence of intracranial hemorrhage (ICH) on the CT-scan&#xD;
&#xD;
               -  Symptoms suggestive of subarachnoid hemorrhage, even if CT-scan is normal&#xD;
&#xD;
               -  Administration of heparin within 48 hours preceding the onset of stroke with an&#xD;
                  elevated activated partial thromboplastin time (aPTT) at presentation&#xD;
&#xD;
               -  A combination of previous stroke and diabetes mellitus&#xD;
&#xD;
               -  Prior stroke or head trauma within the past 3 months&#xD;
&#xD;
               -  Platelet count of less than 100,000/mm3&#xD;
&#xD;
               -  Systolic blood pressure&gt;185 mm Hg, or diastolic blood pressure&gt;110 mm Hg, or&#xD;
                  aggressive management (IV medication) is necessary to reduce blood pressure to&#xD;
                  these limits&#xD;
&#xD;
               -  Blood glucose&lt;50mg/dl or &gt;400 mg/dl&#xD;
&#xD;
          4. Acute stroke patients between the age of ≤ 18 or ≥ 80 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Plasminogen Activator</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/NCT02229799
org study id: 135.315
nct id: NCT02229799
lead sponsor: 
The objectives of this study are to review the safety and efficacy of Actilyse Vial
      (hereafter referred to as "Actilyse") in post-marketing use for treatment of acute ischemic
      stroke, through investigating followings;

        1. Unknown adverse events (especially serious adverse events)

        2. Frequency (Incidence) and trend of adverse events under the actual practice

        3. Factors on the safety profile of Actilyse

        4. Factors on the efficacy profile of Actilyse
observational model: Cohort
time perspective: Prospective
measure: Clinical effectiveness assessed by 30 days-mortality
time frame: 30 days
measure: Number of patients with adverse events
time frame: up to 30 days
measure: Number of patients with clinically significant abnormal findings in physical examination
time frame: up to 30 days
arm group label: Stroke patients
intervention type: Drug
intervention name: Actilyse
arm group label: Stroke patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 79 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Tissue Plasminogen Activator