| Title: |
Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED):an open-label, multicentre, randomised controlled trial |
| Authors: |
van der Steen,Wouter; van de Graaf,Rob A; Chalos,Vicky; Lingsma,Hester F; van Doormaal,Pieter Jan; Coutinho,Jonathan M; Emmer,Bart J; de Ridder,Inger; van Zwam,Wim; van der Worp, H Bart; van der Schaaf, Irene; Gons,Rob A R; Yo,Lonneke S F; Boiten,Jelis; van den Wijngaard,Ido; Hofmeijer,Jeannette; Martens,Jasper; Schonewille,Wouter; Vos,Jan Albert; Tuladhar,Anil Man; de Laat,Karlijn F; van Hasselt,Boudewijn; Remmers,Michel; Vos,Douwe; Rozeman,Anouk; Elgersma,Otto; Uyttenboogaart,Maarten; UMC,Amsterdam; van Tuijl,Julia; Boukrab,Issam; van den Berg,René; Beenen,Ludo F M; Roosendaal,Stefan D; Postma,Alida Annechien; Krietemeijer,Menno; Lycklama,Geert; Meijer,Frederick J A; Hammer,Sebastiaan; van der Hoorn,Anouk; Yoo,Albert J; Gerrits,Dick; Truijman,Martine T B; Zinkstok,Sanne; Koudstaal,Peter J; Manschot,Sanne; Kerkhoff,Henk; Nieboer,Daan; Berkhemer,Olvert; Wolff,Lennard; van der Sluijs,P Matthijs; MR CLEAN-MED investigators; MS Radiologie; Neurologen; Brain; Circulatory Health |
| Publication Year: |
2022 |
| Subject Terms: |
Adult; Aspirin/therapeutic use; Brain Ischemia/therapy; Heparin/adverse effects; Humans; Magnetic Resonance Imaging; Stroke/etiology; Treatment Outcome; Taverne; General Medicine; Randomized Controlled Trial; Multicenter Study; Journal Article |
| Description: |
BACKGROUND: Aspirin and unfractionated heparin are often used during endovascular stroke treatment to improve reperfusion and outcomes. However, the effects and risks of anti-thrombotics for this indication are unknown. We therefore aimed to assess the safety and efficacy of intravenous aspirin, unfractionated heparin, both, or neither started during endovascular treatment in patients with ischaemic stroke. METHODS: We did an open-label, multicentre, randomised controlled trial with a 2 × 3 factorial design in 15 centres in the Netherlands. We enrolled adult patients (ie, ≥18 years) with ischaemic stroke due to an intracranial large-vessel occlusion in the anterior circulation in whom endovascular treatment could be initiated within 6 h of symptom onset. Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale, and a CT or MRI ruling out intracranial haemorrhage. Randomisation was done using a web-based procedure with permuted blocks and stratified by centre. Patients were randomly assigned (1:1) to receive either periprocedural intravenous aspirin (300 mg bolus) or no aspirin, and randomly assigned (1:1:1) to receive moderate-dose unfractionated heparin (5000 IU bolus followed by 1250 IU/h for 6 h), low-dose unfractionated heparin (5000 IU bolus followed by 500 IU/h for 6 h), or no unfractionated heparin. The primary outcome was the score on the modified Rankin Scale at 90 days. Symptomatic intracranial haemorrhage was the main safety outcome. Analyses were based on intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. This trial is registered with the International Standard Randomised Controlled Trial Number, ISRCTN76741621. FINDINGS: Between Jan 22, 2018, and Jan 27, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-treat population. On Feb 4, 2021, after unblinding ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text/plain |
| Language: |
English |
| ISSN: |
0140-6736 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/447623 |
| Availability: |
https://dspace.library.uu.nl/handle/1874/447623 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.FEACBD91 |
| Database: |
BASE |