Brain infarction Ischemic Stroke
Conditions
Interventions
Treatment with unfractionated heparin in a low dose (loading dose of 5000 IU
followed by 500 IU/hour x 6 hours). Treatment with IV acetylsalicylic acid (300
mg). At 24 hours after start of IAT, all
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a clinical diagnosis of acute ischemic stroke; caused by proximal intracranial anterior circulation occlusion (distal intracranial carotid artery or middle (M1/proximal M2) or anterior (A1/A2) cerebral artery confirmed by neuro-imaging (CTA or MRA); CT or MRI ruling out intracranial hemorrhage; treatment possible (groin puncture) within 6 hours from symptom onset or last seen well; a score of at least 2 on the NIH Stroke Scale; age of 18 years or older; written informed consent (deferred).
Exclusion criteria
Exclusion criteria: - Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2; - Treatment with IV alteplase, despite the following contra-indications for IV alteplase: cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging, previous intracerebral hemorrhage in the previous 3 months, INR exceeding 1.7, prior use of direct oral anticoagulant (DOAC) - IV alteplase infusion >4.5 hours after symptom onset; - Contra-indications for ASA/unfractionated heparin, for instance: allergy, recent hemorrhage, heparin induced thrombocytopenia; - INR exceeding 3.0 - Known hemorrhagic diathesis or known thrombopenia (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the score on the modified Rankin Scale (mRS) 90 days after inclusion in the study. The primary effect parameter is defined as the relative risk for improvement on the mRS estimated as an odds ratio with ordinal logistic regression. Multivariable regression analysis will be used to adjust for chance imbalances in main prognostic variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include mortality at 90 days, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS) at 24 hours and 5-7 days, recanalization on postprocedural DSA (measured with the extended treatment in cerebral ischemia (eTICI)) and on CTA at 24 hours +/- 12 hours or MRA at 24-48 hours and infarct size at 5-7 days, or 24-48 hours when MRI per performed, and dichotomized mRS, death, score on the EQ5D-5L and Barthel index at 90 days. In a subset of 600 patients we will assess reperfusion and infarct size with MRI. Safety endpoints include symptomatic intracerebral hemorrhage. Tertiary objectives are 1) to collect (waste) biomaterials (including thrombo-emboli, aspirate blood) and to analyze biofactors in blood samples with respect to their potential for treatment effect modification, 2) to collect and analyze data regarding the deferred consent procedure and its association with patient recall and satisfaction at three months from randomization, and 3) to study the efficiency of national IAT implementation, given the availability of IAT hospitals and capacity, and travel times of ambulance services. To this end, we aim to collect data (time delays and diagnostics) from each step in the acute stroke pathway as input parameters for a simulation model. This way we can study the regional set-up of the IAT organizational model. Other outcome measures are mRS, quality of life score (EQ5D-5L), major vascular events, health care amount and loss of productivity measured once at max 36 months after stroke, in patients who were included in the trial after august 1, 2020. | — |
Countries
Netherlands
Outcome results
None listed