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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Faculty of Meddcine Siriraj Hospital, Mahidol University
  Bangkok, Bangkok, Thailand Recruiting
• Faculty of Medicine, Chulalongkorn University,
  Bangkok, Bangkok, Thailand Recruiting
• Faculty of Medicine, Ramathibodi Hospital, Mahidol University
  Bangkok, Bangkok, Thailand Recruiting
• Faculty of Medicine, Vajira Hospital, Navamindradhiraj University
  Bangkok, Bangkok, Thailand Recruiting
• Central Chest Institute of Thailand
  Nonthaburi, Changwat Nonthaburi, Thailand Recruiting
• Faculty of Medicine, Prince of Songkla University
  Songkhla, Changwat Songkhla, Thailand Recruiting

Study contacts

• Principal investigator: Rungroj Krittayaphong, MD,FESC,FACC — Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university
• Study coordinator: Pontawee Kaewcomdee, B.N.S
• Email: pontawee.k@gmail.com
• Phone: 0815594286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.