<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/NCT02229890</url>
  </required_header>
  <id_info>
    <org_study_id>135.317</org_study_id>
    <nct_id>NCT02229890</nct_id>
  </id_info>
  <brief_title>An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke</brief_title>
  <official_title>SITS-NEW Safe Implementation of Thrombolysis in Stroke in the Non EU-World: An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen&#xD;
      Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute&#xD;
      ischemic stroke&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2006</start_date>
  <primary_completion_date type="Actual">March 2009</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>Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition)</measure>
    <time_frame>up to 36 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with functional independence (independence for activities of daily living)</measure>
    <time_frame>3 months</time_frame>
    <description>Rankin score 0-2</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">593</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Acute ischemic stroke within three hours after symptom onset</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alteplase</intervention_name>
    <arm_group_label>Acute ischemic stroke within three hours after symptom onset</arm_group_label>
    <other_name>Actilyse®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute ischemic stroke within three hours after symptom onset treated at stroke centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male inpatients&#xD;
&#xD;
          -  Age 18 - 80 years&#xD;
&#xD;
          -  Clinical diagnosis of ischemic stroke causing a measurable neurological deficit&#xD;
             defined as impairment of language, motor function, cognition, gaze, vision and/or&#xD;
             neglect. Ischemic stroke is defined as an event characterized by sudden onset of acute&#xD;
             focal neurological deficit, presumed to be caused by cerebral ischemia, after CT scan&#xD;
             exclusion of hemorrhage&#xD;
&#xD;
          -  Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment&#xD;
&#xD;
          -  Stroke symptoms present for at least 30 minutes and not significantly improved before&#xD;
             treatment. Symptoms must be distinguishable from an episode of generalized ischemia&#xD;
             (i.e. syncope), seizure, or migraine disorder&#xD;
&#xD;
          -  Patients are willing to receive thrombolysis treatment and to give informed consent&#xD;
             with regard to retrieval and storage of data and follow up procedures, according to&#xD;
             the regulations in participating countries&#xD;
&#xD;
          -  Willingness and ability to comply with the observational study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of intracranial hemorrhage (ICH) on the CT-scan.&#xD;
&#xD;
          -  Symptoms of ischemic attack began more than 3 hours prior to infusion start or when&#xD;
             time of symptom onset is unknown&#xD;
&#xD;
          -  Symptoms of acute ischemic stroke that were either rapidly improving or only minor&#xD;
             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;
          -  History of previous stroke or serious head-trauma within three months&#xD;
&#xD;
          -  Administration of heparin within the previous 48 hours preceding the onset of stroke&#xD;
             with an elevated activated thromboplastin time (aPTT) at presentation&#xD;
&#xD;
          -  A combination of previous stroke and concomitant diabetes&#xD;
&#xD;
          -  Platelet count of below 100,000/mm³&#xD;
&#xD;
          -  Systolic blood pressure &gt;185 mmHg or diastolic blood pressure &gt;110 mmHg, or aggressive&#xD;
             management (repeated IV medication) necessary to reduce BP to these limits.&#xD;
&#xD;
          -  Blood glucose &lt;50 or &gt; 400 mg/dl&#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;
          -  History or evidence or suspicion of intracranial hemorrhage including sub-arachnoid&#xD;
             hemorrhage&#xD;
&#xD;
          -  Severe uncontrolled arterial hypertension&#xD;
&#xD;
          -  Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or&#xD;
             spinal surgery)&#xD;
&#xD;
          -  Hemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate&#xD;
             hemorrhagic retinopathy) or other hemorrhagic ophthalmic conditions&#xD;
&#xD;
          -  Bacterial endocarditis, pericarditis&#xD;
&#xD;
          -  Prolonged or traumatic cardiopulmonary resuscitation (&gt;2 minutes), obstetrical&#xD;
             delivery within the past 10 days, recent puncture of a non-compressible blood-vessel&#xD;
             (e.g. subclavian or jugular vein puncture)&#xD;
&#xD;
          -  Acute pancreatitis&#xD;
&#xD;
          -  Documented ulcerative gastrointestinal disease during the last 3 months&#xD;
&#xD;
          -  Arterial aneurysm, arterial/venous malformation&#xD;
&#xD;
          -  Neoplasm with increased bleeding risk&#xD;
&#xD;
          -  Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension&#xD;
             (oesophageal varices) and active hepatitis&#xD;
&#xD;
          -  Major surgery or significant trauma in past 10 days (this includes any trauma&#xD;
             associated with current acute myocardial infarction), recent trauma to head or cranium&#xD;
&#xD;
          -  Hypersensitivity to the active substance alteplase or to any of the excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 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 3, 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 3, 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>Stroke</mesh_term>
  </condition_browse>
  <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/NCT02229890
org study id: 135.317
nct id: NCT02229890
lead sponsor: 
Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen
      Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute
      ischemic stroke
observational model: Cohort
time perspective: Prospective
measure: Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition)
time frame: up to 7 days
measure: Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition)
time frame: up to 36 hours
measure: Mortality rate
time frame: up to 6 months
measure: Number of patients with functional independence (independence for activities of daily living)
time frame: 3 months
description: Rankin score 0-2
arm group label: Acute ischemic stroke within three hours after symptom onset
intervention type: Drug
intervention name: alteplase
arm group label: Acute ischemic stroke within three hours after symptom onset
other name: Actilyse®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Stroke
mesh term: Tissue Plasminogen Activator