CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 4,000 target
Drug / intervention
No interventionother
Likely dose
Not stated in record
Key inclusion· 2
  • Age 18 years or older
  • Atrial fibrillation diagnosed by 12-lead ECG or ambulatory ECG monitoring
Key exclusion· 11
  • Ischemic stroke within past 3 months
  • Platelet count <100,000/mm³ or myeloproliferative disorders
  • Hyperviscosity syndrome, DIC, or antiphospholipid syndrome
  • Mechanical prosthetic heart valve

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06396299
NCT06396299N/ARecruitingOn TrackUpdated 13mo ago

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

Mahidol University·observational·Posted May 2, 2024·Updated May 9, 2025

In Brief

An observational study evaluating No intervention for Atrial Fibrillation. Currently recruiting, targeting 4,000 participants across 33 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesThailand

Timeline

N/ARecruiting
202520262027202820292030
First PostedMay 2, 2024
Enrollment StartJun 2, 2024
Primary CompletionJun 1, 2029
Study CompletionJun 1, 2030
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 2.2 years agoPrimary completion in 2.9 years

Interventions

No interventionother

No intervention