Investigation of optimal anticoagulation strategy for stroke prevention in Japanese patients with atrial fibrillation—The J-RHYTHM Registry study design

Abstract

In order to prevent stroke in atrial fibrillation (AF) lower international normalized ratios (INR) (1.6-2.6) were recommended for elderly Japanese patients, but only one clinical study supported this recommendation. The J-RHYTHM Registry is a large, contemporary, prospective observational investigation, with a 2-year follow-up, of patients with AF. Over 6000 AF patients of all types under clinical observation at approximately 150 sites in 10 geographical regions that together cover the whole of Japan will be enrolled in numbers proportional to the population densities of those areas. The primary endpoints of the study will be symptomatic stroke including transient ischemic attack, systemic thromboembolism, and major bleeding including intracranial hemorrhage requiring hospitalization. At each visit, the accumulated demographic data and INR will be examined to determine the appropriate INR for Japanese AF patients. The study will offer a contemporary overview of the anticoagulation status throughout Japan, and will follow more than 6000 patients spread throughout the country for 2 years, to obtain important information, including the optimal INR for Japanese AF patients (UMIN Clinical Trials Registry UMIN000001569).