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Observational study on anticoagulant use and outcomes in patients with atrial fibrillation in Thailand

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

Observational Mahidol University · NCT06396299

This study looks at how well new blood thinners work for people with atrial fibrillation in Thailand and whether they cause major bleeding problems.

Quick facts

Study typeObservational
Enrollment4000 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorMahidol University Academic / other
Locations33 sites (Bangkok, Bangkok and 32 other locations)
Trial IDNCT06396299 on ClinicalTrials.gov

What this trial studies

The COOL-AF Phase 2 study is a prospective observational multicenter study aimed at understanding the patterns of antithrombotic use and their clinical outcomes in patients with atrial fibrillation (AF) in Thailand. It will enroll 3,680 patients over a two-year period from 33 centers, following them every six months for up to three years. The study focuses on the impact of non-vitamin K antagonist oral anticoagulants (NOACs) on rates of major bleeding and other outcomes, particularly in the context of the higher bleeding risks faced by Asian patients with AF.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of non-valvular atrial fibrillation.

Not a fit: Patients who have experienced an ischemic stroke within the past three months or have certain hematological disorders or mechanical heart valves may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for atrial fibrillation, potentially reducing the incidence of major bleeding and improving patient outcomes.

How similar studies have performed: Other studies have shown success with similar observational approaches in understanding anticoagulant use and outcomes, but this specific focus on Asian populations and NOACs is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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:

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

Where this trial is running

Bangkok, Bangkok and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial Fibrillationatrial fibrillationischemic strokemajor bleedingdeathoral anticoagulant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.