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

Mahidol University

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06396299

COA-CREC103-2023

Details and patient eligibility

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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

4,000 participants in 1 patient group

Patients diagnosed with atrial fibrillation

Treatment:

Other: No intervention