Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Dec;5(4):414-422.
doi: 10.1177/2396987320954671. Epub 2020 Sep 3.

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

Kristin Tveitan Larsen  1   2 , Elisabeth Forfang  2 , Johanna Pennlert  3 , Eva-Lotta Glader  3 , Christina Kruuse  4 , Per Wester  3   5 , Hege Ihle-Hansen  2   6 , Maria Carlsson  7   8 , Eivind Berge  1 , Rustam Al-Shahi Salman  9 , Torgeir Bruun Wyller  1   2 , Ole Morten Rønning  2   10
Affiliations

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

Kristin Tveitan Larsen et al. Eur Stroke J. 2020 Dec.

Abstract

Background and aims: 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: 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.Trial status: Recruitment to STudy of Antithrombotic Treatment after IntraCerebral Haemorrhage is on-going. On 30 April 2020, 44 participants had been enrolled in 31 participating hospitals. An individual patient-data meta-analysis is planned with similar randomised trials.

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

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.
STATICH flowchart.
See this image and copyright information in PMC

References

    1. Antithrombotic Trialists Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324: 71–86. - PMC - PubMed
    1. Baigent C, Blackwell L, Collins R, et al.. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373: 1849–1860. - PMC - PubMed
    1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146: 857–867. - PubMed
    1. Ruff CT, Giugliano RP, Braunwald E, et al.. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 2014; 383: 955–962. - PubMed
    1. van Asch CJ, Luitse MJ, Rinkel GJ, et al.. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol 2010; 9: 167–176. - PubMed

LinkOut - more resources