SITS-IVT in Patients >80 Years Study

NCT04260347 | Completed Results

• 1 other identifier: 0135-0344
• Study Type: observational
• Target: 1,655
• Locations: 1 country
• Sites: 1

Brief Summary

A non-interventional post-approval study on Safe Implementation of Treatment in Stroke - International Stroke Thrombolysis Register (SITS-ISTR) existing data of intravenous recombinant tissue plasminogen Activator (rt-PA) (0.9 mg/kg) in acute ischaemic stroke patients over 80 years, treated according to the Summary of Product Characteristics (SmPC) in European countries.

Conditions

Ischaemic Stroke

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition

  Defined as the number of participants presenting intracerebral haemorrhage (parenchymatous haemorrhage type 2, PH2), at the 22-36 hours post-treatment scan or earlier, if clinically indicated, combined with neurological deterioration leading to an increase of 4 points on the National Institutes of Health Stroke Scale (NIHSS) from baseline to 24h or death within 24 hours (SITS-MOST definition). The NIHSS is a neurological examination tool used to objectively quantify stroke severity. It is composed by 11 items, 3 of which with more than one component, scoring between 0 (normal function) and 2, 3, 7 or 8 (highest degree of impairment) for a specific ability (item). The sum of the individual scores from each item originate the total NIHSS score, where: 0 = no stroke symptoms; 1-4 = minor stroke; 5-15 = moderate stroke; 16-20 = moderate to severe stroke; and 21-42 = severe stroke.

  Up to 36 hours after stroke onset, between June 2015 and December 2021

• Mortality Within 90 Days, Defined as the Number of Participants With a Death Event

  Number of participants who died within 90 days as classified by the investigator according to cause: cerebral infarct, cerebral haemorrhage, cerebral infarct and haemorrhage unspecified, myocardial infarct, pulmonary embolism, pneumonia, other vascular cause, unknown and other cause of death. The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) was used.

  Up to 90 days after stroke onset, between June 2015 and December 2021

• Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days

  Defined as the number of participants classified with a modified Rankin score (mRS) of 0, 1 or 2 within 90 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The score has a scale from 0 to 6, where: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance; 3 = moderate disability, requiring some help but able to walk without assistance; 4 = moderately severe disability, unable to walk without assistance and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent and requiring constant nursing care and attention; and 6 = dead.

  Up to 90 days after stroke onset, between June 2015 and December 2021

Secondary Outcomes (6)

• Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS)

  At baseline, defined as the ischaemic stroke hospital admission date, between June 2015 and December 2021

• Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days

  Up to 90 days after stroke onset, between June 2015 and December 2021

• Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition

  Up to 7 days after stroke onset, between June 2015 and December 2021

• Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment

  Up to 4.5 hours after stroke onset, between June 2015 and December 2021

• Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital)

  Up to 4.5 hours after stroke onset, between June 2015 and December 2021

Study Arms (2)

Actilyse® (alteplase) pre-approval

Drug: Alteplase

Actilyse® (alteplase) post-approval

Drug: Alteplase

Interventions

Alteplase DRUG

Intravenous injection

Also known as: Actilyse®

Actilyse® (alteplase) post-approval; Actilyse® (alteplase) pre-approval

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 80 years old presenting with acute ischaemic stroke (AIS) symptoms for which thrombolysis treatment was initiated within 4.5 hours after stroke onset according to the SmPC.

You may qualify if:

• Patients over 80 years old presenting with acute ischaemic stroke symptoms for which thrombolysis treatment was initiated within 4.5 hours after stroke onset according to SmPC are included.
• Patients over 80 years who received thrombolysis according to SmPC for acute ischaemic stroke (AIS) within 4.5 hours after stroke onset during the period (approximately 3 years) prior to July 2018 are included.

You may not qualify if:

• Contraindication(s) to the use of IV thrombolysis per local SmPC.
• Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of index event and for the duration of the data collection.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 7, 2020
• Study Start: May 14, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)