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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02229890
Collaborator
(none)
593
Enrollment

Study Details

Study Description

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 Phase

Study Design

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 :
Jun 1, 2006
Actual Primary Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Acute ischemic stroke within three hours after symptom onset

Drug: alteplase
Other Names:
  • Actilyse®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition) [up to 7 days]

    2. Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition) [up to 36 hours]

    3. Mortality rate [up to 6 months]

    Secondary Outcome Measures

    1. Number of patients with functional independence (independence for activities of daily living) [3 months]

      Rankin score 0-2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT02229890
    Other Study ID Numbers:
    • 135.317
    First Posted:
    Sep 3, 2014
    Last Update Posted:
    Sep 3, 2014
    Last Verified:
    Aug 1, 2014
    Additional relevant MeSH terms:
    Stroke
    Tissue Plasminogen Activator

    Study Results

    No Results Posted as of Sep 3, 2014