Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in The Netherlands for Late Arrivals: MR CLEAN LATE

Phase 3

Recruiting

• Conditions: brain infarction; ischemic stroke; 10007963; 10014523

• Registration Number: NL-OMON55450
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

o clinical diagnosis of acute ischemic stroke,
o caused by proximal intracranial anterior circulation occlusion (distal
intracranial carotid artery or middle (M1/M2 ) cerebral artery confirmed by
neuro-imaging (CTA),
o and presence of poor*, moderate or good collateral flow as shown by
neuro-imaging (CTA)
o CT or MRI ruling out intracranial hemorrhage,
o Start of IA treatment (groin puncture) possible between 6 and 24 hours or
last seen well < 24 hours including wake-up strokes,
o a score of at least 2 on the NIH Stroke Scale
o age of 18 years or older
o Written informed consent (deferred)
* Inclusion and randomization will be restricted to patients with moderate or
good collaterals when 100 patients with poor collaterals have been included in
the study.

Exclusion Criteria

o Pre-stroke disability which interferes with the assessment of functional
outcome at 90 days, i.e. mRS >2
o cerebral infarction in the previous 6 weeks with residual neurological
deficit or signs of recent infarction on neuroimaging in the territory of the
middle cerebral artery
o INR exceeding 3.0*
o platelet count < 40 x 109/L*
o APTT > 50 sec*
o visible infarction in > 1/3 of the territory of the middle cerebral artery
o participation in trials other than current and MR ASAP.
o ICA-T/M1 occlusion, NIHSS >=10, infarct core <=25ml and a mismatch ratio total
ischemic volume/ infarct core >=2 (patient is eligible for direct EVT treatment,
based on DAWN/DEFUSE 3 patient profile)
Inclusion in other intervention trials during the study period is not allowed
* In case there is no clinical indication to test for hemorrhagic diathesis, it
may be assumed that the INR, APTT and platelet count are within these limits.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the score on the mRS 90 days after inclusion in the<br /><br>study. The primary effect parameter should take the whole range of the mRS into<br /><br>account and is defined as the relative risk for improvement on the mRS<br /><br>estimated as a common odds ratio with ordinal logistic regression.<br /><br>Multivariable regression analysis will be used to adjust for chance imbalances<br /><br>in main prognostic variables between the intervention and control group, such<br /><br>as age, stroke severity (NIHSS), time since onset, previous stroke, atrial<br /><br>fibrillation and diabetes mellitus. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include hemorrhage and stroke severity at 24 hours and 5-7<br /><br>days, recanalization on CTA at 24 hours or MRA at 24-48 hours and when chosen<br /><br>for CTA at 24 hours; infarct size at 5-7 days on non-contrast CT will follow. </p><br>