Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06396299

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Death Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Meddcine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Rate of warfarin and NOACs use

    Time frame: 3 years

  2. Rate of ischemic stroke/TIA

    Time frame: 3 years

  3. Rate of systemic embolism

    Time frame: 3 years

  4. Rate of intracranial hemorrhage

    Time frame: 3 years

  5. Rate of major bleeding

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Pontawee Kaewcomdee, B.N.S

CONTACT

[email protected]

0815594286

Rungroj Krittayaphong, MD,FESC,FACC

CONTACT

[email protected]

092-2071250

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Health Systems Research Institute,Thailand
  • The Heart Association of Thailand

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
May 2, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.