COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2 - Trial NCT06396299

Timeline & Enrollment

Primary Outcome

Rate of warfarin and NOACs use,Rate of ischemic stroke/TIA,Rate of systemic embolism,Rate of intracranial hemorrhage,Rate of major bleeding

Summary

Atrial fibrillation (AF) is a leading cause of cardiovascular mortality and morbidity. Asian
 patients with AF have a higher rate of major bleeding including intracranial hemorrhage (ICH)
 compared to non-Asians. Non-vitamin K antagonist oral anticoagulants (NOACs) are the safer
 drugs compared to warfarin due to a lower rate of ICH, but the rate of NOACs use in many
 Asian AF is much lower than non-Asian countries due to economic concerns. The purpose of the
 COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation
 (COOL-AF) Phase 2 registry is to determine the changes in antithrombotic patterns and the
 impact on clinical outcomes.
 
 The COOL-AF Phase 2 study is a prospective observational multicenter study of patients with
 known or newly diagnosed non-valvular AF in Thailand. The aim is a sample size is 3680
 patients from 33 centers within a 2-years enrollment timeline. Patients will be follow-up
 every 6 months until 3 years. The study outcomes were death, ischemic stroke/systemic
 embolism, major bleeding, myocardial infarction, heart failure, and quality of life.

ICD-10 Classifications