Trial reportTrials2015
Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF): study protocol for a randomised controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 4 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 66 citations in OpenAlex.
- Antithrombotic treatment after stroke due to intracerebral haemorrhage.The Cochrane database of systematic reviews · 2023Pooled it
- Multiple versus fewer antiplatelet agents for preventing early recurrence after ischaemic stroke or transient ischaemic attack.The Cochrane database of systematic reviews · 2020Pooled it
- Resuming anticoagulants after anticoagulation-associated intracranial haemorrhage: systematic review and meta-analysis.BMJ open · 2018Pooled it
- Antithrombotic treatment after stroke due to intracerebral haemorrhage.The Cochrane database of systematic reviews · 2017Pooled it
- Timing of anticoagulation for venous thromboembolism after recent traumatic and vascular brain Injury.Journal of thrombosis and thrombolysis · 2023Article
- Article
- Review
- Restarting anticoagulant therapy after intracranial hemorrhage in patients with atrial fibrillation: A nationwide retrospective cohort study.International journal of cardiology. Heart & vasculature · 2022Article
- Anticoagulant Reversal in Gastrointestinal Bleeding: Review of Treatment Guidelines.Digestive diseases and sciences · 2021Review
- Atrial Fibrillation in Spontaneous Intracerebral Hemorrhage, Dijon Stroke Registry (2006-2017).Journal of the American Heart Association · 2021Article
- Re-initiation of anticoagulation after central nervous system hemorrhage during treatment with direct oral anticoagulants: a single hospital cohort study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021Article
- Article
- Long-term prognosis after intracerebral haemorrhage.European stroke journal · 2020Article
- Ten-year risks of recurrent stroke, disability, dementia and cost in relation to site of primary intracerebral haemorrhage: population-based study.Journal of neurology, neurosurgery, and psychiatry · 2020Article
- Long-term outcome of resuming anticoagulation after anticoagulation-associated intracerebral hemorrhage.eNeurologicalSci · 2020Article
- Risk of Recurrent Bleeding Events in Nonvalvular Atrial Fibrillation Treated with Vitamin K Antagonists: A Clinical Practice Research Datalink Study.TH open : companion journal to thrombosis and haemostasis · 2019Article
- Antithrombotic treatment for secondary prevention of stroke and other thromboembolic events in patients with stroke or transient ischemic attack and non-valvular atrial fibrillation: A European Stroke Organisation guideline.European stroke journal · 2019Article
- Antithrombotic Therapy to Prevent Recurrent Strokes in Ischemic Cerebrovascular Disease: JACC Scientific Expert Panel.Journal of the American College of Cardiology · 2019Review
- Anticoagulants in Older Patients with Nonvalvular Atrial Fibrillation after Intracranial Hemorrhage.Journal of stroke · 2019Article
- Observational
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is a marked lack of evidence on the optimal prevention of ischaemic stroke and other thromboembolic events in patients with non-valvular atrial fibrillation and a recent intracerebral haemorrhage during treatment with oral anticoagulation. These patients are currently treated with oral anticoagulants, antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional preferences. Compared with warfarin, the direct oral anticoagulant apixaban reduces the risk of stroke or systemic embolism, intracranial haemorrhage, and case fatality in patients with atrial fibrillation. Compared with aspirin, apixaban reduces the risk of stroke or systemic embolism in patients with atrial fibrillation, and has a similar risk of intracerebral haemorrhage. Novel oral anticoagulants have not been evaluated in patients with atrial fibrillation and a recent intracerebral haemorrhage. To inform a phase III trial, the phase II Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF) trial aims to obtain estimates of the rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated intracerebral haemorrhage treated with apixaban and in those in whom oral anticoagulation is avoided. METHODS/
designAPACHE-AF is a phase II, multicentre, open-label, parallel-group, randomised clinical trial with masked outcome assessment. One hundred adults with a history of atrial fibrillation and a recent intracerebral haemorrhage during treatment with anticoagulation in whom clinical equipoise exists on the optimal stroke prevention strategy will be enrolled in 14 hospitals in The Netherlands. These patients will be randomly assigned in a 1:1 ratio to either apixaban or to avoiding oral anticoagulation. Patients in the control group may be treated with antiplatelet drugs at the discretion of the treating physician. The primary outcome is the composite of vascular death or non-fatal stroke during follow-up. We aim to include 100 patients in 2.5 years. All patients will be followed-up for the duration of the study, but at least for 1 year. Recruitment commenced in September 2014 and is ongoing. This trial is funded by the Dutch Heart Foundation (2012 T077) and ZonMW (015008048).
trial registrationNTR4526 (16 April 2014).
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