NL-OMON53150
Completed
Phase 3
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. - MR CLEAN-MED
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Brain infarction
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 1500
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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;
Outcomes
Primary Outcomes
Not specified
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