STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage: Protocol for a randomised controlled trial.

Intracerebral haemorrhage anticoagulant antiplatelet antithrombotic treatment atrial fibrillation ischaemic events randomised controlled trial secondary prevention stroke

Journal

European stroke journal
ISSN: 2396-9881
Titre abrégé: Eur Stroke J
Pays: England
ID NLM: 101688446

Informations de publication

Date de publication:
Dec 2020
Historique:
received: 13 05 2020
accepted: 29 07 2020
entrez: 18 2 2021
pubmed: 19 2 2021
medline: 19 2 2021
Statut: ppublish

Résumé

Many patients with prior intracerebral haemorrhage have indications for antithrombotic treatment with antiplatelet or anticoagulant drugs for prevention of ischaemic events, but it is uncertain whether such treatment is beneficial after intracerebral haemorrhage. STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage will assess (i) the effects of long-term antithrombotic treatment on the risk of recurrent intracerebral haemorrhage and occlusive vascular events after intracerebral haemorrhage and (ii) whether imaging findings, like cerebral microbleeds, modify these effects. STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is a multicentre, randomised controlled, open trial of starting versus avoiding antithrombotic treatment after non-traumatic intracerebral haemorrhage, in patients with an indication for antithrombotic treatment. Participants with vascular disease as an indication for antiplatelet treatment are randomly allocated to antiplatelet treatment or no antithrombotic treatment. Participants with atrial fibrillation as an indication for anticoagulant treatment are randomly allocated to anticoagulant treatment or no anticoagulant treatment. Cerebral CT or MRI is performed before randomisation. Duration of follow-up is at least two years. The primary outcome is recurrent intracerebral haemorrhage. Secondary outcomes include occlusive vascular events and death. Assessment of clinical outcomes is performed blinded to treatment allocation. Target recruitment is 500 participants.

Sections du résumé

BACKGROUND AND AIMS OBJECTIVE
Many patients with prior intracerebral haemorrhage have indications for antithrombotic treatment with antiplatelet or anticoagulant drugs for prevention of ischaemic events, but it is uncertain whether such treatment is beneficial after intracerebral haemorrhage. STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage will assess (i) the effects of long-term antithrombotic treatment on the risk of recurrent intracerebral haemorrhage and occlusive vascular events after intracerebral haemorrhage and (ii) whether imaging findings, like cerebral microbleeds, modify these effects.
METHODS METHODS
STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is a multicentre, randomised controlled, open trial of starting versus avoiding antithrombotic treatment after non-traumatic intracerebral haemorrhage, in patients with an indication for antithrombotic treatment. Participants with vascular disease as an indication for antiplatelet treatment are randomly allocated to antiplatelet treatment or no antithrombotic treatment. Participants with atrial fibrillation as an indication for anticoagulant treatment are randomly allocated to anticoagulant treatment or no anticoagulant treatment. Cerebral CT or MRI is performed before randomisation. Duration of follow-up is at least two years. The primary outcome is recurrent intracerebral haemorrhage. Secondary outcomes include occlusive vascular events and death. Assessment of clinical outcomes is performed blinded to treatment allocation. Target recruitment is 500 participants.

Identifiants

pubmed: 33598560
doi: 10.1177/2396987320954671
pii: 10.1177_2396987320954671
pmc: PMC7856578
doi:

Types de publication

Journal Article

Langues

eng

Pagination

414-422

Subventions

Organisme : Medical Research Council
ID : G1002605
Pays : United Kingdom
Organisme : British Heart Foundation
ID : PG/14/50/30891
Pays : United Kingdom
Organisme : British Heart Foundation
ID : FS/13/72/30531
Pays : United Kingdom
Organisme : British Heart Foundation
ID : CS/18/2/33719
Pays : United Kingdom
Organisme : British Heart Foundation
ID : SP/12/2/29422
Pays : United Kingdom

Informations de copyright

© European Stroke Organisation 2020.

Déclaration de conflit d'intérêts

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JP has served on a scientific advisory board for and received lecture fees from Bayer. CK has received lecture fees from Novo Nordic and Bristol-Myers Squibb Denmark. The other authors declare that they have no competing interests.

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Auteurs

Kristin Tveitan Larsen (KT)

Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.
University of Oslo, Institute of Clinical Medicine, Oslo, Norway.

Elisabeth Forfang (E)

University of Oslo, Institute of Clinical Medicine, Oslo, Norway.

Johanna Pennlert (J)

Department of Public Health and Clinical Medicine, Umeå University Hospital, Umeå, Sweden.

Eva-Lotta Glader (EL)

Department of Public Health and Clinical Medicine, Umeå University Hospital, Umeå, Sweden.

Christina Kruuse (C)

Herlev Gentofte Hospital and University of Copenhagen, Herlev, Denmark.

Per Wester (P)

Department of Public Health and Clinical Medicine, Umeå University Hospital, Umeå, Sweden.
Department of Clinical Sciences, Karolinska Institute, Danderyds Hospital, Stockholm, Sweden.

Hege Ihle-Hansen (H)

University of Oslo, Institute of Clinical Medicine, Oslo, Norway.
Department of Neurology, Oslo University Hospital, Oslo, Norway.

Maria Carlsson (M)

Department of Neurology, Nordland Hospital Trust, Bodø, Norway.
Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.

Eivind Berge (E)

Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.

Rustam Al-Shahi Salman (R)

Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.

Torgeir Bruun Wyller (T)

Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.
University of Oslo, Institute of Clinical Medicine, Oslo, Norway.

Ole Morten Rønning (OM)

University of Oslo, Institute of Clinical Medicine, Oslo, Norway.
Department of Neurology, Akershus University Hospital, Lørenskog, Norway.

Classifications MeSH