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

Last updated: May 7, 2025
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Arrhythmia

Treatment

No intervention

Clinical Study ID

NCT06396299
COA-CREC103-2023
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients who have experienced an ischemic stroke within the past 3 months beforeenrollment.

  2. Patients with a platelet count less than 100,000/mm3 or who have myeloproliferativedisorders (essential thrombocythemia, chronic myeloid leukemia, polycythemia vera,agnogenic myeloid metaplasia), hyperviscosity syndrome, chronic disseminatedintravascular 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 otherdiseases, 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 1month.Contact/Locations

Study Design

Total Participants: 4000
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
June 02, 2024
Estimated Completion Date:
June 01, 2030

Connect with a study center

  • Bhumibol Adulyadej Hospital

    Bangkok,
    Thailand

    Active - Recruiting

  • Charoen Krung Pracha Rak Hospital

    Bangkok,
    Thailand

    Active - Recruiting

  • Faculty of Meddcine Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Faculty of Medicine, Chulalongkorn University,

    Bangkok,
    Thailand

    Active - Recruiting

  • Faculty of Medicine, Ramathibodi Hospital, Mahidol University

    Bangkok,
    Thailand

    Active - Recruiting

  • Faculty of Medicine, Vajira Hospital, Navamindradhiraj University

    Bangkok,
    Thailand

    Active - Recruiting

  • Phramongkutklao College of Medicine

    Bangkok,
    Thailand

    Site Not Available

  • Police General Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Rajavithi Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Prapokklao Hospital (Chanthaburi),

    Chanthaburi,
    Thailand

    Site Not Available

  • Faculty of Medicine, Chiang Mai University,

    Chiang Mai,
    Thailand

    Active - Recruiting

  • Nakornping Hospital

    Chiang Mai,
    Thailand

    Site Not Available

  • Chiangrai Prachanukroh Hospital

    Chiang rai,
    Thailand

    Site Not Available

  • Chonburi Hospital

    Chon buri,
    Thailand

    Active - Recruiting

  • Queen Savang Vadhana Memorial Hospital

    Chon buri,
    Thailand

    Active - Recruiting

  • Faculty of Medicine, Khon Kaen University

    Khon Kaen,
    Thailand

    Active - Recruiting

  • Lampang Hospital

    Lampang,
    Thailand

    Site Not Available

  • Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University

    Nakhon Nayok,
    Thailand

    Site Not Available

  • Golden Jubilee Medical Center

    Nakhon Pathom,
    Thailand

    Site Not Available

  • Maharat Nakorn Ratchasima Hospital

    Nakhon Ratchasima,
    Thailand

    Active - Recruiting

  • Sawanpracharak Hospital

    Nakhon Sawan,
    Thailand

    Active - Recruiting

  • Central Chest Institute of Thailand

    Nonthaburi,
    Thailand

    Active - Recruiting

  • Faculty of Medicine, Thammasat University, Rangsit Campus

    Pathumthani,
    Thailand

    Active - Recruiting

  • Buddhachinaraj Hospital

    Phitsanulok,
    Thailand

    Site Not Available

  • Faculty of Medicine, Naresuan University

    Phitsanulok,
    Thailand

    Site Not Available

  • Vachira Phuket Hospital

    Phuket,
    Thailand

    Active - Recruiting

  • Ratchaburi Hospital

    Ratchaburi,
    Thailand

    Active - Recruiting

  • Sakonnakhon Hospital

    Sakon nakhon,
    Thailand

    Site Not Available

  • Faculty of Medicine, Prince of Songkla University

    Songkla,
    Thailand

    Active - Recruiting

  • Suratthani Hospital

    Surat thani,
    Thailand

    Active - Recruiting

  • Surin Hospital

    Surin,
    Thailand

    Active - Recruiting

  • Sunpasitthiprasong Hospital

    Ubon Ratchathani,
    Thailand

    Active - Recruiting

  • Udonthani Hospital

    Udon thani,
    Thailand

    Active - Recruiting

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