RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

No intervention

Locations (20)

Faculty of Meddcine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Faculty of Medicine, Chulalongkorn University,

Bangkok, Bangkok, Thailand

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Faculty of Medicine, Vajira Hospital, Navamindradhiraj University

Bangkok, Bangkok, Thailand

Phramongkutklao College of Medicine

Bangkok, Bangkok, Thailand

Police General Hospital

Bangkok, Bangkok, Thailand

Central Chest Institute of Thailand

Nonthaburi, Changwat Nonthaburi, Thailand

Faculty of Medicine, Prince of Songkla University

Songkhla, Changwat Songkhla, Thailand

Faculty of Medicine, Chiang Mai University,

Chiang Mai, Chiang Mai, Thailand

Bhumibol Adulyadej Hospital

Bangkok, Thailand

Charoen Krung Pracha Rak Hospital

Bangkok, Thailand

Rajavithi Hospital

Bangkok, Thailand

Prapokklao Hospital (Chanthaburi),

Chanthaburi, Thailand

Nakornping Hospital

Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand

Chonburi Hospital

Chon Buri, Thailand

Queen Savang Vadhana Memorial Hospital

Chon Buri, Thailand

Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand

Lampang Hospital

Lampang, Thailand

Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University

Nakhon Nayok, Thailand