Title: PRODAST: Prospective Record Of the use of Dabigatran in patients with Acute Stroke or TIA NCT No.: NCT02507856 Version: 5.0 Date: September 24th, 2018 page 1 of 59 PRODAST v5.0 24th September 2018 TITLE PAGE Non-interventional Post-Authorisation Safety Study (PASS) Protocol Investigational Pradaxa, vitamin K antagonists, antiplatelet therapy Product(s): Title: PRODAST: Prospective Record Of the use of Dabigatran in patients with Acute Stroke or TIA Chairman of the Prof. Dr. Hans-Christoph Diener Steering Committee: Department of Neurology, University Hospital Essen University Duisburg-Essen, Germany http://www.uni-due.de/neurologie/ Phone: +49 201/ 723-2460 Fax: +49 201/ 723-5901 e-mail:
[email protected] Co-Chairman of the Prof. Dr. Christian Weimar Steering Committee: Department of Neurology, University Hospital Essen University Duisburg-Essen, Germany Hufelandstr. 55, 45122 Essen Phone: +49 201/ 723-6503 Fax: +49 201/ 723-6948 e-mail:
[email protected] Epidemiology Prof. Dr. Andreas Stang, MPH University Hospital Essen Head of the Center of Clinical Epidemiology c/o Institute of Medical Informatics, Biometry and Epidemiology (IMIBE) Hufelandstr. 55, D-45147 Essen, Germany Phone: +49 201 / 92 239-290 Fax: +49 201 / 92 239-310 e-mail:
[email protected] Data management University Hospital Essen and Monitoring Center for Clincial Trials (ZKSE), c/o Institute of Medical Informatics, Biometry and Epidemiology (IMIBE) University Duisburg-Essen Hufelandstraße 55, D-45122 Essen, Germany Phone: +49 201 / 92 239-233 Fax: +49 201 / 92 239-310 e-mail:
[email protected] Status: Protocol final version Version 5.0 Date: September 24th, 2018 page 2 of 59 PRODAST v5.0 24th September 2018 SIGNATURES The present study protocol was subject to critical review and has been approved in the present version by the undersigning persons.