COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
Recruiting · NCT06396299 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mahidol University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
- Patients who have experienced an ischemic stroke within the past 3 months before enrollment.
- 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.
- Patients with a mechanical prosthetic heart valve.
- Patients with rheumatic mitral stenosis.
- Patients participating in research projects with concealed treatments.
- 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.
- Pregnancy.
- Patients unable to follow the treatment plan.
- Patients who do not consent to participate in the study.
- Patients who are hospitalized or discharged from the hospital within the past 1 month.Contact/Locations
Where it is running
33 locations listed.
- 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
- Golden Jubilee Medical Center - Nakhon Pathom, Thailand
- Maharat Nakorn Ratchasima Hospital - Nakhon Ratchasima, Thailand
- Sawanpracharak Hospital - Nakhon Sawan, Thailand
- Faculty of Medicine, Thammasat University, Rangsit Campus - Pathum Thani, Thailand
- Buddhachinaraj Hospital - Phitsanulok, Thailand
- Faculty of Medicine, Naresuan University - Phitsanulok, Thailand
- Vachira Phuket Hospital - Phuket, Thailand
- Ratchaburi Hospital - Ratchaburi, Thailand
- Sakonnakhon Hospital - Sakon Nakhon, Thailand
- Suratthani Hospital - Surat Thani, Thailand
- Surin Hospital - Surin, Thailand
- Sunpasitthiprasong Hospital - Ubon Ratchathani, Thailand
- Udonthani Hospital - Udon Thani, Thailand
- 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