N/A
Completed N=1,655
SITS-IVT in Patients >80 Years Study
Source: ClinicalTrials.gov NCT04260347 ↗Enrolled (actual)
1,655
Serious AEs
—
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition — 14; 15 Participants — p=1.000
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition |
14; 15 | 1.000 |
| PRIMARY Mortality Within 90 Days, Defined as the Number of Participants With a Death Event |
161; 149 | 0.254 |
| PRIMARY Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days |
205; 233 | 0.280 |
| SECONDARY Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS) |
10.5; 11 | 0.916 |
| SECONDARY Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days |
142; 158 | 0.561 |
| SECONDARY Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition |
24; 30 | 0.522 |
| SECONDARY Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment |
153; 151 | 0.810 |
| SECONDARY Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital) |
93; 88 | 0.179 |
| SECONDARY Door to Needle Time |
46; 48 | 0.275 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04260347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.