NCT06396299

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

Mahidol University·ClinicalTrials.gov·otherNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Atrial Fibrillation
Drug/Device/Intervention
No intervention
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Mahidol University
Location
Bangkok,Bangkok,Bangkok,Bangkok,Bangkok,Bangkok,Bangkok,Bangkok,Bangkok,Chanthaburi,Chiang Mai,Chiang Mai,Chiang rai,Chon buri,Chon buri,Khon Kaen,Lampang,Nakhon Nayok,Nakhon Pathom,Nakhon Ratchasima,, Thailand
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Jun 01, 2030
Enrollment
4000 participants
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
Chronic atrial fibrillationPersistent atrial fibrillationParoxysmal atrial fibrillationAtrial fibrillation and flutterAtrial fibrillation and atrial flutter, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06396299
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06396299 through Pure Global AI's free database. This phase not specified trial is sponsored by Mahidol University and is currently Not yet recruiting. The study focuses on Atrial Fibrillation. Target enrollment is 4000 participants.

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