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

Recruitingn/aAges 18 Years - 100 YearsAllMahidol University
NCT06396299 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring. Exclusion Criteria: 1. Patients who have experienced an ischemic stroke within the past 3 months before enrollment. 2. Patients with a platelet count less than 100,000/mm3 or who have myeloproliferative disorders (essential thrombocythemia, chronic myeloid leukemia, polycythemia vera, agnogenic myeloid metaplasia), hyperviscosity syndrome, chronic disseminated intravascular coagulation (DIC), or antiphospholipid syndrome. 3. Patients with a mechanical prosthetic heart valve. 4. Patients with rheumatic mitral stenosis. 5. Patients participating in research projects with concealed treatments. 6. Patients expected to have a life expectancy of less than 3 years due to other diseases, such as cancer or AIDS, as determined from medical records. 7. Pregnancy. 8. Patients unable to follow the treatment plan. 9. Patients who do not consent to participate in the study. 10. Patients who are hospitalized or discharged from the hospital within the past 1 month.Contact/Locations
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What it tests

  • No intervention
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Where

33 sites
Faculty of Meddcine Siriraj Hospital, Mahidol University
Bangkok, Thailand
Faculty of Medicine, Chulalongkorn University,
Bangkok, Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Thailand
Faculty of Medicine, Vajira Hospital, Navamindradhiraj University
Bangkok, Thailand
Phramongkutklao College of Medicine
Bangkok, Thailand
Police General Hospital
Bangkok, Thailand
Central Chest Institute of Thailand
Nonthaburi, Thailand
Faculty of Medicine, Prince of Songkla University
Songkhla, Thailand

…and 25 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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