Outcomes of real-world patients with non-valvular atrial fibrillation on anticoagulants ineligible for Phase III trials of direct oral anticoagulants

Running title: Real-world patients with NVAF

Mayumi Higa¹, Takeshi Morimoto², Masayuki Ikeda³, Shinichiro Ueda^1,4,5

¹Department of Clinical Research and Management, University of the Ryukyus Graduate School of Medicine, Okinawa, Japan.

²Department of Clinical Epidemiology, Hyogo Medical University, Hyogo, Japan.

³ Department of Medical Informatics, Kagawa University School of Medicine, Kagawa, Japan.

⁴ Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus Graduate School of Medicine, Okinawa, Japan.

⁵ Department of Health Data Science, Yokohama City University Graduate School of Data Science, Yokohama, Japan

Correspondence:

Dr Shinichiro Ueda, Department of Clinical Pharmacology & Therapeutics,

University of the Ryukyus Graduate School of Medicine, Okinawa, 903-0215 Japan

Email:blessyou@med.u-ryukyu.ac.jp

ORCID ID https://orcid.org/0000-0001-8133-9361

Phone: +81-98-895-1195

The authors confirm that the Principal Investigator for this paper is Dr Shinichiro Ueda and that he had direct clinical responsibility for patients.

Keywords: non-valvular atrial fibrillation, anticoagulation, Phase III trial, eligibility

Word count: 2469

Table count: 5

Figure count: 2