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An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02229890
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment
Stroke Drug: alteplase

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Study Type : Observational
Actual Enrollment : 593 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : June 2006
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Group/Cohort Intervention/treatment
Acute ischemic stroke within three hours after symptom onset Drug: alteplase
Other Name: Actilyse®

Primary Outcome Measures :
  1. Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition) [ Time Frame: up to 7 days ]
  2. Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition) [ Time Frame: up to 36 hours ]
  3. Mortality rate [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Number of patients with functional independence (independence for activities of daily living) [ Time Frame: 3 months ]
    Rankin score 0-2

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute ischemic stroke within three hours after symptom onset treated at stroke centers

Inclusion Criteria:

  • Female or male inpatients
  • Age 18 - 80 years
  • Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischemic stroke is defined as an event characterized by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischemia, after CT scan exclusion of hemorrhage
  • Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment
  • Stroke symptoms present for at least 30 minutes and not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder
  • Patients are willing to receive thrombolysis treatment and to give informed consent with regard to retrieval and storage of data and follow up procedures, according to the regulations in participating countries
  • Willingness and ability to comply with the observational study protocol

Exclusion Criteria:

  • Evidence of intracranial hemorrhage (ICH) on the CT-scan.
  • Symptoms of ischemic attack began more than 3 hours prior to infusion start or when time of symptom onset is unknown
  • Symptoms of acute ischemic stroke that were either rapidly improving or only minor before start of infusion
  • Severe stroke as assessed clinically and/or by appropriate imaging techniques
  • Seizure at onset of stroke
  • History of previous stroke or serious head-trauma within three months
  • Administration of heparin within the previous 48 hours preceding the onset of stroke with an elevated activated thromboplastin time (aPTT) at presentation
  • A combination of previous stroke and concomitant diabetes
  • Platelet count of below 100,000/mm³
  • Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (repeated IV medication) necessary to reduce BP to these limits.
  • Blood glucose <50 or > 400 mg/dl
  • Significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis
  • Patients receiving oral anticoagulants, e.g. warfarin sodium (INR>1.3)
  • History or evidence or suspicion of intracranial hemorrhage including sub-arachnoid hemorrhage
  • Severe uncontrolled arterial hypertension
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
  • Hemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate hemorrhagic retinopathy) or other hemorrhagic ophthalmic conditions
  • Bacterial endocarditis, pericarditis
  • Prolonged or traumatic cardiopulmonary resuscitation (>2 minutes), obstetrical delivery within the past 10 days, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)
  • Acute pancreatitis
  • Documented ulcerative gastrointestinal disease during the last 3 months
  • Arterial aneurysm, arterial/venous malformation
  • Neoplasm with increased bleeding risk
  • Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
  • Major surgery or significant trauma in past 10 days (this includes any trauma associated with current acute myocardial infarction), recent trauma to head or cranium
  • Hypersensitivity to the active substance alteplase or to any of the excipients

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02229890     History of Changes
Other Study ID Numbers: 135.317
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action