1. 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
- Author
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van Nieuwenhuizen, Koen M., van der Worp, H. Bart, Algra, Ale, Kappelle, L. Jaap, Rinkel, Gabriel J. E., van Gelder, Isabelle C., Schutgens, Roger E. G., Klijn, Catharina J. M., Roos, Yvo B. W. E. M., Kerkhoff, Henk, Schreuder, Antonia H. C. M. L., Remmers, Michel J. M., Dippel, Diederik W. J., Bienfait, H. Paul, Wermer, Marieke J. H., Staals, Julie, den Hertog, Heleen M., van Dijk, Ewoud J., Hofmeijer, Jeannette, van Tuijl, Jordie H., van den Berg-Vos, Renske M., Luijckx, Gert-Jan, Remmers, Heerlen Michel J. M., Schutgens, Rogier E. G., Tuinenburg, Anton E., Koudstaal, Peter J., Boersma, Hendrikus, Chamuleau, Steven A. J., Cardiology, Klinische Neurowetenschappen, RS: CARIM - R3 - Vascular biology, RS: CARIM School for Cardiovascular Diseases, Amsterdam Cardiovascular Sciences, Amsterdam Neuroscience, Neurology, Other departments, and Cardiovascular Centre (CVC)
- Subjects
Time Factors ,INTRACRANIAL HEMORRHAGE ,Administration, Oral ,Medicine (miscellaneous) ,THERAPY ,Clinical Trial, Phase II ,law.invention ,RISK STRATIFICATION ,RESUMPTION ,Study Protocol ,Clinical Protocols ,Randomized controlled trial ,Risk Factors ,law ,Antithrombotic ,ORAL ANTICOAGULATION ,Pharmacology (medical) ,Apixaban ,Non-U.S. Gov't ,Stroke ,Netherlands ,Randomised controlled trial ,Aspirin ,ISCHEMIC-STROKE SUBTYPES ,Research Support, Non-U.S. Gov't ,Atrial fibrillation ,Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3] ,Clinical Trial ,Phase II ,Multicenter Study ,Treatment Outcome ,Research Design ,Anesthesia ,Randomized Controlled Trial ,Platelet aggregation inhibitor ,medicine.drug ,medicine.medical_specialty ,Pyridones ,Research Support ,WARFARIN ,Internal medicine ,Journal Article ,medicine ,MANAGEMENT ,Humans ,Comparative Study ,cardiovascular diseases ,Cerebral Hemorrhage ,business.industry ,Warfarin ,Anticoagulants ,medicine.disease ,EFFICACY ,Antiplatelet drugs ,ASPIRIN ,Intracerebral haemorrhage ,Pyrazoles ,business ,Platelet Aggregation Inhibitors ,Factor Xa Inhibitors - Abstract
Background There 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/Design APACHE-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 registration NTR4526 (16 April 2014). Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0898-4) contains supplementary material, which is available to authorized users.
- Published
- 2015