Multicenter Randomized CLinical trial of endovascular treatment for acute ischemic stroke in the Netherlands. The effect of periprocedural MEDication: heparin, antiplatelet agents, both or neither.

Phase 3

Completed

Conditions: Brain infarction
Ischemic Stroke
10007963
10003184
10014523

Registration Number: NL-OMON53150

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1500

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

- 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 (<90^9/L)
- Therapeutic heparin use

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the score on the modified Rankin Scale (mRS) 90 days<br /><br>after inclusion in the study. The primary effect parameter is defined as the<br /><br>relative risk for improvement on the mRS estimated as an odds ratio with<br /><br>ordinal logistic regression. Multivariable regression analysis will be used to<br /><br>adjust for chance imbalances in main prognostic variables. </p><br>

Secondary Outcome Measures