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 1

• Conditions: Acute ischemic stroke; MedDRA version: 20.0Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000013700; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001466-21-NL
• Lead Sponsor: Erasmus MC University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-09
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1500

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
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified