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Safe Implementation of Thrombolysis in Stroke - Monitoring Study

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: NCT02229812
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to evaluate the safety and efficacy of intravenous alteplase within 3 hours of symptom onset in acute ischemic stroke patients

Condition or disease Intervention/treatment
Stroke Drug: alteplase

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Study Type : Observational
Actual Enrollment : 6475 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safe Implementation of Thrombolysis in Stroke - Monitoring Study (SITS-MOST)
Study Start Date : December 2002
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Group/Cohort Intervention/treatment
thrombolytic therapy in stroke Drug: alteplase

Primary Outcome Measures :
  1. Occurrence of symptomatic intracerebral hemorrhage (SICH) [ Time Frame: up to 36 hours ]
  2. Mortality rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Independence for activities of daily living [ Time Frame: 3 months ]
    modified Ranking Scale 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 stroke patients in the European Union

Inclusion Criteria:

  • Female or male in-patient
  • 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 that had 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 of data and follow up procedures, according to the regulations in participating countries
  • Willingness and ability to comply with the 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
  • Minor neurological deficit or symptoms rapidly improving before start of infusion
  • Severe stroke as assessed clinically and/or by appropriate imaging techniques
  • Seizure at onset of stroke
  • Symptoms suggestive of subarachnoid hemorrhage, even if the CT-scan is normal
  • Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
  • Patients with any history of prior stroke and concomitant diabetes
  • Prior stroke within the last 3 months
  • Platelet count of below 100,000/mm³
  • Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits
  • Blood glucose <50 or > 400 mg/dl
  • Known hemorrhagic diathesis
  • Patients receiving oral anticoagulants, e.g. warfarin sodium
  • Manifest or recent severe or dangerous bleeding
  • Known history of or suspected intracranial hemorrhage
  • Suspected subarachnoid hemorrhage or condition after subarachnoid hemorrhage from aneurysm
  • 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)
  • Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture
  • Bacterial endocarditis, pericarditis
  • Acute pancreatitis
  • Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation
  • Neoplasm with increased bleeding risk
  • Severe liver disease, including hepatic failure, cirrhosis, portal hypertension oesophageal varices) and active hepatitis
  • Major surgery or significant trauma in past 3 months

All in- and exclusion criteria follow the summary of product characteristics of Actilyse®

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02229812     History of Changes
Other Study ID Numbers: 135.313
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 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