The AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke randomized trial: Rationale and methods

Abstract

Survival analysis and the log-rank test will be used to compare treatment groups according to the intention-to-treat principle, including participants who require open-label anticoagulation for newly detected atrial fibrillation. Study outcomes The primary efficacy outcome is recurrent stroke of any type. The primary safety outcomes are symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage. Discussion ARCADIA is the first trial to test whether anticoagulant therapy reduces stroke recurrence in patients with atrial cardiopathy but no known atrial fibrillation.

Vergangenheit und Zukunft des ESUS-Konzepts

“…Die ARCADIA-Studie (The AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke randomized trial) ist eine multizentrische, randomisierte, doppelblinde Studie in den Vereinigten Staaten bei Patienten mit ESUS und einer Kardiopathie des linken Vorhofs. Vorhofkardiopathie wurde definiert als ≥ 1 der folgenden Marker: P-Wellen-Terminalforce >5000 μV × ms in der EKG-Ableitung V1, Serum NT-proBNP >250 pg/ml und Index des linken Vorhofdurchmessers ≥3 cm/m 2 im Echokardiogramm [26]. Verglichen werden Apixaban 5 mg 2-mal täglich mit 81 mg Aspirin 1-mal täglich.…”

Secondary prevention of ischaemic stroke

“…The core concept of ESUS is being used as the basis for adding other markers to provide a more refined subpopulation that may benefit from anticoagulation. The ARCADIA study (AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke) is investigating the use of apixaban in patients with ESUS plus markers of atrial cardiopathy (≥1 of: P‐wave terminal force >5000 μV × ms in electrocardiogram (ECG) lead V 1 , serum N‐terminal prohormone of brain natriuretic peptide >250 pg./mL or left atrial diameter index ≥3 cm/m 2 on echocardiography) . If positive, there may be ongoing interest in studying and treating patients with ‘ESUS plus’.…”

Embolic Stroke of Unknown Source Clinical Trials and Advances in Research

“…It may be that some patients with ESUS will respond to anticoagulants, similarly to a cardioembolic patient with diagnosed AF. Dr. Kamel offers experience and insight on the many exciting, ongoing research efforts that are helping to answer this question, such as the AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA trial) 4 and the Apixaban for Treatment of Embolic Stroke of Undetermined Source (ATTICUS trial). 5 As a principal investigator for the ARCADIA trial, Dr. Kamel explains that the underlying premise of this study is that some of the patients with ESUS have experienced a stroke because of a thrombus that arises from the left atrium, in the absence of AF.…”