Abstract | BACKGROUND: 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).
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Authors | Koen M van Nieuwenhuizen, H Bart van der Worp, Ale Algra, L Jaap Kappelle, Gabriel J E Rinkel, Isabelle C van Gelder, Roger E G Schutgens, Catharina J M Klijn, APACHE-AF Investigators |
Journal | Trials
(Trials)
Vol. 16
Pg. 393
(Sep 04 2015)
ISSN: 1745-6215 [Electronic] England |
PMID | 26340977
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Factor Xa Inhibitors
- Platelet Aggregation Inhibitors
- Pyrazoles
- Pyridones
- apixaban
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Topics |
- Administration, Oral
- Anticoagulants
(administration & dosage, adverse effects)
- Atrial Fibrillation
(blood, complications, diagnosis, drug therapy, mortality)
- Cerebral Hemorrhage
(blood, chemically induced, diagnosis, drug therapy, mortality)
- Clinical Protocols
- Factor Xa Inhibitors
(adverse effects, therapeutic use)
- Humans
- Netherlands
- Platelet Aggregation Inhibitors
(adverse effects, therapeutic use)
- Pyrazoles
(adverse effects, therapeutic use)
- Pyridones
(adverse effects, therapeutic use)
- Research Design
- Risk Factors
- Stroke
(blood, diagnosis, etiology, mortality, prevention & control)
- Time Factors
- Treatment Outcome
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