Safe Implementation of Treatments in Stroke (SITS) - Intravenous thrombolysis in acute ischaemic stroke patients over 80 years, SITS-IVT>80 years study (SITS ELDERLY)

Study identification

• EU PAS number:
  EUPAS33011
• Study ID:
  33012
• Official title and acronym:
  Safe Implementation of Treatments in Stroke (SITS) - Intravenous thrombolysis in acute ischaemic stroke patients over 80 years, SITS-IVT>80 years study (SITS ELDERLY)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Cyprus

  Denmark

  Finland

  France

  Germany

  Greece

  Iceland

  Ireland

  Italy

  Luxembourg

  Malta

  Netherlands

  Norway

  Portugal

  Spain

  Sweden

  United Kingdom
• Study description:
  The SITS-IVT>80 years is a retrospective study based on datacollected in the SITS-ISTR setting from acute ischemic strokepatients > 80 years of age. The study aims to evaluate theincidence rate with 95% CI of SICH, death and functionalindependence/favourable outcome within 90 days for ischaemicstroke patients treated with rt-PA in clinical routine settings. Inthe proposed SITS-IVT>80 years study using the SITS registrywe plan to identify approximately 1000 patients older than 80years treated with IV Alteplase otherwise fulfilling SmPCcriteria in the post-approval period of 3 years (from 1 July 2018to 30 June 2021) and also to identify 1000 patients older than 80years treated with IV Alteplase otherwise fulfilling SmPCcriteria in the pre-approval period of 3 years (from June 2015 toJune 2018). In both periods, at least 500 patients should beregistered from centres of European countries being part of themutual recognition.The objective of the SITS-IVT>80 years is to compare the safetyand other outcome parameters between the post-approval >80years and pre-approval >80 years AIS patients using the dataalready collected in SITS-ISTR.
• Study status:
  Planned

Research institutions and networks

Institutions

Karolinska University Hospital

Networks

Safe Implementation of Treatments in Stroke (SITS)

Study timelines

Date when funding contract was signed

Planned: 22/01/2020

Study start date

Planned: 17/02/2020

Date of final study report

Planned: 01/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Boehringer Ingelheim Study Number 0135-0344