EUCTR2017-001466-21-NL
Active, not recruiting
Phase 1
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
Erasmus MC University Medical Center0 sites1,500 target enrollmentAugust 9, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC University Medical Center
- Enrollment
- 1500
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- a clinical diagnosis of acute ischemic stroke;
- •\- caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2\) 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •\- Pre\-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS \>2
- •\- Contra\-indications for ASA/unfractionated heparin, for instance: allergy, recent surgery, heparin induced thrombocytopenia.
- •\- INR exceeding 3\.0
- •\- Thrombocyte count \<1009/L
- •\- Treatment with IV alteplase despite the following contra\-indications for IV alteplase:
- •o cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging,
- •o previous intracerebral hemorrhage within the previous 3 months,
- •o INR exceeding 1\.7,
- •o prior use of direct oral anticoagulant (DOAC),
- •o IV alteplase infusion \>4\.5 hours after symptom onset.
Outcomes
Primary Outcomes
Not specified
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