Stroke Trials Registry

SITS-ISTR
Safe Implementation of Thrombolysis in Stroke International Stroke Thrombolysis Register

Principal Investigator
Nils G. Wahlgren, M.D., Ph.D.

PI Address
The Stroke Research Unit
Department of Neurology
Karolinska Hospital S-171
76 Stockholm
Sweden
email: nils.wahlgren@karolinska.se

Contact Address
Lena Lundqvist, R.N.,
Research Coordinator

Contact Email
lena.lundqvist@ks.se

Sponsor

Study Size Actual:	1476
Study Size Planned:	1500
Max Time from onset:	3 Hours
Follow-up Duration:	3 Months

Status:
As of April 2004, 1476 patients had been enrolled.

Purpose:
To generate a database of clinical information regarding patients treated with tissue plasminogen activator (tPA) within 3 hours of acute stroke.

Interventions:

Tissue plasminogen activator
Thrombolytic

Location(s):
Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK

Year Started: 2002

Year Finished: 2006

Year Presented: 2010

Design:
International register of tPA-treated stroke patients. Data will be used in the SITS-MOST trial.

Inclusion Criteria
Patients treated with tPA within 3 hours of ischemic stroke will be eligible for this study.

Patient Involvement:
Patients will be treated according to their clinician's discretion.

Primary Outcome:
SITS-ISTR is a register. Data will be entered into the registry regarding the time delay between symptom onset and treatment initiation, age, gender, stroke risk factors, stroke subtype, imaging before and after treatment (CT- measured infarct volume, MRI with optional PWI-DWI mismatch, and transcranial Doppler sonography), National Institutes of Health Stroke Scale (NIHSS) score 1 and 24 hours after treatment, tPA dosage, global effects, hemorrhagic events, stroke etiology, and modified Rankin scale (MRS) score at 3 months.

Results:
In the 3—4·5-h cohort, treatment was started at a median of 55 min later after symptom onset (195 min [IQR 187—210] vs 140 min [115—165], p<0·0001), median age was 3 years younger (65 years [55—73] vs 68 years [58—74], p<0·0001), and stroke severity was lower (NIHSS score 11 [7—16] vs 12 [8—17], p<0·0001) than in the 3-h cohort. We recorded no significant differences between the 3—4·5-h cohort and the within 3-h cohort for any outcome measure—rate of symptomatic intracerebral haemorrhage: 2·2% (14 of 649) versus 1·6% (183 of 11 681) (odds ratio [OR] 1·18 [95% CI 0·89—1·55], p=0·24; adjusted OR 1·32 [1·00—1·75], p=0·052); mortality: 12·7% (70 of 551) versus 12·2% (1263 of 10 368) (OR 1·02 [0·90—1·17]; p=0·72; adjusted OR 1·15 [1·00—1·33]; p=0·053); and independence: 58·0% (314 of 541) versus 56·3% (5756 of 10231) (OR 1·04 [0·95—1·13], p=0·42; adjusted OR 0·93 [0·84—1·03], p=0·18).

Source of Information:
http://www.acutestroke.org
Presented at European Stroke Conference [May 2010]

Web Links and Publications:

Relationship of blood pressure, antihypertensive therapy, and outcome in ischemic stroke treated with intravenous thrombolysis: retrospective analysis from Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register (SITS-ISTR).
Stroke 2009 Jul;40(7):2442-9

[Thrombolytic therapy for acute ischemic stroke. Experience of SITS (Safe Implementation of Thrombolysis in Stroke) register.]
Neurologia 2009 Jun;24(5):288-91

Thrombolysis with alteplase 3-4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study.
Lancet 2008 Oct 11;372(9646):1303-9

The International Stroke Thrombolysis Register for Safe Implementation of Thrombolysis in Stroke (SITS). 2001 European Stroke Conference.

SITS

This information last updated on: 6/1/2010

Reviewed on: 10/07/2009.

UID: 196