Third International Stroke Trial (IST-3) of thrombolysis for acute ischaemic stroke - IST-3

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3100

Inclusion Criteria

•Symptoms and signs of clinically definite acute stroke.
•Time of stroke onset is known and treatment can be started within six hours of this onset.
•CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g cerebral tumour).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•The patient has previously been randomised in IST-3
•Major surgery, trauma (e.g. major fall at time of stroke) or gastrointestinal or urinary tract haemorrhage within the previous 21 days. Arterial puncture at a non-compressible site within the previous 7 days.
•Any known defect in coagulation (e.g. currently on oral anticoagulants with an INR > 1.3 OR current treatment with heparin [unless APPT within normal laboratory limits] OR treatment with low molecular weight heparin or heparinoid OR treatment with ximelagatran).
•Known defect of clotting or platelet function (but patients on antiplatelet agents can be randomised).
•The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
•Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0 mmol/L ('stick testing' is a sufficiently accurate test for this purpose).
•Symptoms considered likely to resolve completely within the next few hours (i.e. a TIA)
•Patient has had a stroke within the previous 14 days or has had treatment for acute ischaemic stroke with thrombolytic therapy within the past 14 days.
•Patient was already dependent in activities of daily living before the present acute stroke
•Patient has other life threatening illness (e.g. advanced cancer) likely to lead to death within a few months.
•Likely to be unavailable for follow-up e.g. no fixed home address.
•Patient has Blood Pressure < 90 mm Hg or > 220 mm Hg or Diastolic Blood Pressure < 40 mm Hg or > 130 mm Hg

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety and efficacy of treatment with intravenous recombinant tissue plasminogen activator (rt-PA) within 6 hours of onset of acute ischaemic stroke. ;Secondary Objective: These will include exploration of the interaction between stroke severity,<br>brain imaging appearances and time from onset of symptoms, to identify those<br>patients who have the most the gain (or lose) from thrombolytic treatment;<br>examination of the risks of intracranial haemorrhage identified by repeat<br>brain imaging; and longer-term outcome to provide reliable estimates on the<br>cost-effectiveness of trial treatment.<br>;Primary end point(s): The proportion of patients alive and independent at 6 months

Secondary Outcome Measures

Name	Time	Method

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