Research

Below are our ongoing, planned and completed studies or projects.

Ongoing studies or projects

SITS AF Study 2

A retrospective and prospective study to investigate the type, timing, safety and reasons for choice of acute interventions in patients taking direct OACs or warfarin prior to stroke onset. This study shall also evaluate the use of idarucizumab in patients on dabigatran suffering acute stroke.

SITS IVT Pediatric Study

Until recently, IVT with alteplase was not approved in patients with acute ischaemic stroke aged under 18 years. Based on observational data, regulatory authorities in several countries have now approved use of IVT with alteplase in patients 16-18 years, if other Summary of Product Criteria (SmPC) are fulfilled. Regulatory authorities have requested monitoring of treatment in this age group, SITS will therefore perform a study of IVT in patients with acute ischaemic stroke aged 16-18 years. The study protocol was recently approved by the Swedish ethics committee.
We encourage all SITS centres to participate in this study and interested centres can inform their paediatric department about the upcoming study.

SITS-TEST

The SITS Tenecteplase in Ischemic Stroke Monitoring Study (SITS-TEST): In the SITS IVT registry, it is now possible to enter whether tenecteplase is used as IVT therapy in acute ischemic stroke. SITS is planning an observational study of safety and outcome of intravenous tenecteplase in acute stroke in routine clinical use.

SITS Collaborative Project ESO-Angels / WSO-Angels

The European Stroke Organisation (ESO) and World Stroke Organisation (WSO) is currently implementing a Europe-wide and a world-wide project respectively aiming to stimulate high quality in stroke management by awarding excellent performance in key quality factors such as high proportion of ischaemic stroke patients undergoing reperfusion treatment, door-to-needle time, and proportion of patients treated in stroke units. Based on requests from numerous SITS users, we created the SITS-Quality Registry (SITS-QR) which can be used by SITS centres, including those participating in the ESO-Angels Award Program or the Angels Program outside ESO member countries.

SITS IVT >80 years Study

A prospective, post-approval registry of intravenous rt-PA (0.9 mg/kg) in acute ischaemic stroke patients over 80 years within the SITS-ISTR Registry. Although IVT in patients >80 years has been used off-label in many countries, treatment in patients >80 years will probably increase further after approval. The SITS-ISTR provides an instrument for continuous monitoring of thrombolysis treatment in stroke, and provides a technical platform for the SITS >80 years post-approval study.
At least 1000 patients from approximately 60 European sites are planned to be registered in this prospective study.

SITS Cerebral Oedema Study

Large hemispheric infarction often leads to high morbidity and mortality and real-world data on clinical management, outcomes and healthcare utilization is limited. There is also a growing interest in understanding the efficacy and effectiveness on thrombectomy in patients with large infarcts. The number of incidents, current clinical management, recurrent strokes and functional outcomes, including how thrombectomy modifies the risk of cerebral oedema in patients with large hemispheric infarction, will form the basis for this study.

SITS Fertile Woman Study

A retrospective and prospective study of intravenous rt-PA (0.9 mg/kg) given up to 4.5 hours after symptom onset in female acute ischaemic stroke patients, aged between 13 and 50 years, with particular focus on pregnancy and menstruation.

SITS-MOST II

The SITS Monitoring Study II is an 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. 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. All analyses of main and secondary outcome variables will be done separately per protocol, population and the all patients population.

Planned projects

SITS Seizure Study

A prospective study of seizures in acute stroke patients treated with intravenous rt-PA (0.9 mg/kg) up to 4.5 hours after symptom onset.

SITS Low-dose IVT Study

In many Asian countries, 0.6 mg/kg bodyweight IVT thrombolysis is given instead of 0.9 mg/kg. Although the ENCHANTED trial did not show noninferiority of low-dose alteplase compared to standard-dose alteplase with respect to death and disability at 90 days, significantly fewer symptomatic intracerebral haemorrhages with low-dose alteplase occurred. SITS has now added the option to specify the alteplase dose and data collection is ongoing.

SITS IVT Wake-up Stroke Study

SITS has published one article on IVT in patients with unknown stroke symptom onset. However, the main weakness of the study was missing data on whether the unknown onset time was due to wake-up stroke, the last known well time being known, or truly unknown timepoints. Relevant variables have been added to the registry and data collection is ongoing. Top recruiting centre coordinators will be invited to join as co-authors.

Data Completeness and High Quality Data Entry Project

SITS has started a pilot project to identify causes for incomplete data entry and ways to assist centres to complete and enter high quality data in the SITS registry. National and Local Coordinators will receive reports on data completeness at centers in their respective countries, in order to inform initiatives for improvement. The SITS-EAST Coordination Committee has agreed to start the project in SITS-EAST centres as a pilot project. The project will later be extended to SITS on a global level.

Completed studies

SITS-MOST

An open, prospective, non-randomised observational study of safety and efficacy of treatment with intravenous rt-PA within 3 hours of onset of acute ischaemic stroke, based on the SITS International Stroke Thrombolysis Register. Performed in European Union countries.

SITS-UTMOST

A prospective, post-approval registry study of intravenous rt-PA (0.9 mg/kg) up to 4.5 hours after symptom onset in acute ischaemic stroke patients. The study has been completed and the main results were published in the European Stroke Journal in 2016.

SITS TBY Study

A retrospective and prospective registry study of implementation of thrombectomy in routine clinical practice. The primary results were presented at ESOC 2018 and the manuscript is in its final stage for submission. Two main secondary result papers are also under preparation for submission.

SITS-NEW

An observational study of safety and efficacy of intravenous rt-PA within 3 hours of symptom onset in acute ischaemic stroke patients, according to the Summary of Product Characteristics (SPC) of the countries involved. Performed in India, People´s Republic of China, Singapore and South Korea

SITS-OPEN

An international, multicentre, prospective, controlled, blinded evaluation study of safety and efficacy of thrombectomy in acute occlusive stroke. The SITS-OPEN trial results are under preparation for publication.

SITS AF Study 1

A retrospective and prospective study to identify the safest and most effective time point for initiation of oral anticoagulation (OAC) following ischaemic stroke of different severity in patients with atrial fibrillation.