COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- Rate of warfarin and NOACs use [Time frame: 3 years]
- Rate of ischemic stroke/TIA [Time frame: 3 years]
- Rate of systemic embolism [Time frame: 3 years]
- Rate of intracranial hemorrhage [Time frame: 3 years]
- Rate of major bleeding [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Thailand · 33 centers
- Faculty of Meddcine Siriraj Hospital, Mahidol University — Bangkok
- Faculty of Medicine, Chulalongkorn University, — Bangkok
- Faculty of Medicine, Ramathibodi Hospital, Mahidol University — Bangkok
- Faculty of Medicine, Vajira Hospital, Navamindradhiraj University — Bangkok
- Phramongkutklao College of Medicine — Bangkok
- Police General Hospital — Bangkok
- Central Chest Institute of Thailand — Nonthaburi
- Faculty of Medicine, Prince of Songkla University — Songkhla
- … and 25 more centers
Publications
- Krittayaphong R, Winijkul A, Rungpradubvong V, Apiyasawat S, Phrommintikul A, Chantrarat T, Methavigul K, Chichareon P, Makarawate P, Wongtheptien W, Kaolawanich Y, Lip GYH. The COOL-AF Phase 2 Registry: COhort of Antithrombotic Use and Clinical Outcomes in Atrial Fibrillation Patients. JACC Asia. 2025 Jan 21;5(1):191-202. doi: 10.1016/j.jacasi.2024.10.027. eCollection 2025 Jan. PMID 39896253
Identifiers
NCT: NCT06396299 · COA-CREC103-2023