SITS-MOST II

Summary

The SITS Monitoring Study II An international, prospective, multicentre, observational study of safety and efficacy of treatment interventions in acute stroke in the clinical routine setting

Study Title

The SITS Monitoring Study II (SITS-MOST II): An international, prospective, multicentre, observational study of safety and efficacy of treatments in acute stroke in the clinical routine setting

 

Study Design

International, prospective, multicentre, observational study based on the SITS registry platform, of treatments such as intravenous (i.v) thrombolysis, neurothrombectomy, and secondary prevention, in consecutively enrolled acute stroke patients.  

 

Primary

Hypothesis

Patients with acute stroke receiving treatments will have similar outcomes and similar safety in clinical routine as in the active arms of controlled trials

 

Study Objective

To monitor the safety and benefit of clinical routine treatments for acute stroke, such as i.v thrombolysis, neurothrombectomy, decompressive neurosurgery and secondary prevention, such as, anticoagulants, platelet inhibitors, antihypertensives, and lipid lowering.    

 

Clinical Site Locations

All clinical centres worldwide, performing treatments in acute ischaemic stroke, are encouraged to join if they accept

- to consecutively register all patients meeting criteria

- to accept source data monitoring

- to collaborate on evaluating any adverse reactions

Centres may define whether they prefer to restrict their registrations to certain treatments, such as i.v. thrombolysis or neurothrombectomy, although the requirement of consecutive registration applies to the preferred indication.

 

Enrolment

Patients with acute stroke and agreeing with centre´s preferred treatment registry.

Since this study aims to document treatment in clinical routine, all consecutive patients with the specified treatment for acute stroke will be included in the registry.

Only patients meeting evidence based treatment criteria, the per protocol population, will be considered for the analysis of the primary hypothesis.

 

Primary outcome variables

For efficacy of acute intervention: Functional independence on modified Rankin Scale score at 3 months (mRS 0-2); for efficacy of secondary prevention: Proportion of patients with recurrent stroke or other vascular events within 3 months

For safety of acute intervention: Symptomatic intracranial haemorrhage according to the modified SITS-MOST definitions below; and mortality within 3 months; for safety of secondary prevention: Major intra and extracranial haemorrhage and mortality within 3 months

All analyses of main and secondary outcome variables will be done separately for the per protocol population and the all patients population

 

 

Secondary outcome variables

Proportion of patients with excellent recovery (mRS score 0-1) at 3 months

Neurological improvement (difference in NIHSS from baseline to 2h/12h, to 24h and to 7D after initiation of acute treatment or to discharge if earlier than 7D)

Study outcomes for mild stroke (NIHSS < 7), moderately severe stroke at baseline (NIHSS 7-12) and for severe stroke (NIHSS 13-)

Length of in-hospital stay (days to discharge from in-hospital ward to home/secondary care for survivors)

Number of days the patient stayed at home within the first 3 months after stroke onset

Time between onset of stroke to arrival at hospital, to imaging and to treatment

Systemic embolism (SE), Myocardial infarction (MI), Pulmonary Embolism (PE)

 

Safety outcome variables

 

Symptomatic intracerebral haemorrhage (SICH according to SITS-MOST definition).

Symptomatic intracranial haemorrhage (SICH according to modified SITS-MOST definition); in addition to usual SITS-MOST criteria blood may be anywhere in the intracranial space (including in the intraventricular, intraparenchymal and/or subarachnoid space).

All-cause mortality at 3 months.

Death within 7 days post treatment

Symptomatic intracranial haemorrhage according to NINDS and ECASS II definitions

Distal embolism/reocclusion demonstrated by follow-up CTA/MRA

Any adverse reactions related to treatment