acute ischemic stroke caused by occlusion of a large vessel
Conditions
Brief summary
Primary clinical efficacy endpoints: • mRS favorable (mRS less than or equal to 2) at 90 days. • Change in hyperintense area volume in the DWI and FLAIR sequences between baseline, 7 days and 90 days (where possible). Primary safety endpoints: • Symptomatic intracerebral haemorrhage (sICH) assessed with ECASS 2 criteria within 24 hours (any intracranial haemorrhage with neurological deterioration of at least 4 points on the NIHSS or any fatal haemorrhage)
Detailed description
• Reduction in NIHSS ≥ 4 and ≥ 8 points separately at 24 hrs, 48 hrs, and 7 days • The patient's quality of life within selected domains with Beck Depression Rating Scale, the EQ-5D-5L Scale and the Barthel Scale. • The technical outcome of the procedure (grading the degree of recanalization) assessed with the Thrombolysis in Cerebral Ischemia (TICI) scale.
Interventions
DRUGACETYLSALICYLIC ACID
Sponsors
Medical University Of Gdansk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical efficacy endpoints: • mRS favorable (mRS less than or equal to 2) at 90 days. • Change in hyperintense area volume in the DWI and FLAIR sequences between baseline, 7 days and 90 days (where possible). Primary safety endpoints: • Symptomatic intracerebral haemorrhage (sICH) assessed with ECASS 2 criteria within 24 hours (any intracranial haemorrhage with neurological deterioration of at least 4 points on the NIHSS or any fatal haemorrhage) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Reduction in NIHSS ≥ 4 and ≥ 8 points separately at 24 hrs, 48 hrs, and 7 days • The patient's quality of life within selected domains with Beck Depression Rating Scale, the EQ-5D-5L Scale and the Barthel Scale. • The technical outcome of the procedure (grading the degree of recanalization) assessed with the Thrombolysis in Cerebral Ischemia (TICI) scale. | — |
Countries
Poland
Outcome results
None listed