Endovascular treatment for acute ischemic stroke; the use of periprocedural heparin or antiplatelet agents

Phase 3

Completed

• Conditions: Acute ischemic stroke due to an intracranial large vessel occlusion of the anterior circulation; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN76741621
• Lead Sponsor: Erasmus MC, University Medical Center

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31915166/ protocol (added 16/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35240044/ (added 04/03/2022) 2021 Other publications in https://doi.org/10.1177/23969873211034932 Study progress abstract European Stroke Organisation Conference 2021 (added 29/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-06
• Study Completion: 2022-04-30
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 663

Inclusion Criteria

1. A clinical diagnosis of acute ischemic stroke
2. Caused by a 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)
3. CT or MRI ruling out intracranial hemorrhage
4. Intra-arterial treatment (groin puncture) possible within 0-6 hours
5. A score of at least 2 on the NIH Stroke Scale
6. Age of 18 years or older
7. Written informed consent (deferred)

Exclusion Criteria

1. Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
2. Treatment with IV alteplase despite the following contra-indications for IV alteplase:
2.1. Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging
2.2. Previous intracerebral hemorrhage within the previous 3 months
2.3. INR exceeding 1.7
2.4. Prior use of direct oral anticoagulant (DOAC)
2.5. IV alteplase infusion >4.5 hours after symptom onset
3. Contra-indications for ASA/unfractionated heparin, for instance: allergy, recent surgery, heparin induced thrombocytopenia
4. INR exceeding 3.0
5. Thrombocyte count <100^9/L
6. Participation in trials other than current and MR ASAP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome, measured by the modified Rankin Scale (mRS) at 90 days. Assessment of outcome on the mRS will be performed by independent assessors, blinded to the allocated and actually received treatment. Their assessment will be based on standardized reports of a telephone interview by trained research personnel who are not aware of treatment allocation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Reperfusion grade, measured by the extended treatment in cerebral ischaemia (eTICI) score on final angiography of IAT<br> 2. Symptomatic intra-cranial hemorrhage, according to the Heidelberg criteria<br> 3. Clinical stroke severity, measured by the National Institutes of Health Stroke Scale score at 24 hours, and 5-7 days after randomization, or at discharge<br> 4. Final infarct volume, measured on cranial non-contrast CT or MRI in a subset of 600 patients at 5-7 days after randomization. Infarct size at day 5-7 will be compared with plain CT and perfusion CT results (if available) at baseline<br> 5. Dichotomization of functional outcome, measured by the modified Rankin Scale (mRS) at 90 days<br> 6. Mortality at 90 days<br>