Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, ischemic stroke, major bleeding, death, oral anticoagulant
Brief 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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Health Systems Research Institute,Thailand
The Heart Association of Thailand
Mahidol University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of warfarin and NOACs use | 3 years |
| Rate of ischemic stroke/TIA | 3 years |
| Rate of systemic embolism | 3 years |
| Rate of intracranial hemorrhage | 3 years |
| Rate of major bleeding | 3 years |
Countries
Thailand
Contacts
Primary ContactPontawee Kaewcomdee, B.N.S
Backup ContactRungroj Krittayaphong, MD,FESC,FACC
Outcome results
None listed