COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
1 other identifier
observational
4,000
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 2, 2024
CompletedStudy Start
First participant enrolled
June 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
May 9, 2025
May 1, 2025
5 years
April 19, 2024
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Rate of warfarin and NOACs use
3 years
Rate of ischemic stroke/TIA
3 years
Rate of systemic embolism
3 years
Rate of intracranial hemorrhage
3 years
Rate of major bleeding
3 years
Study Arms (1)
Patients diagnosed with atrial fibrillation
Interventions
Eligibility Criteria
All patients diagnosed with atrial fibrillation
You may qualify if:
- Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mahidol Universitylead
- Health Systems Research Institute,Thailandcollaborator
- The Heart Association of Thailandcollaborator
Study Sites (33)
Faculty of Meddcine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700, Thailand
Faculty of Medicine, Chulalongkorn University,
Bangkok, Bangkok, Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Bangkok, Thailand
Faculty of Medicine, Vajira Hospital, Navamindradhiraj University
Bangkok, Bangkok, Thailand
Phramongkutklao College of Medicine
Bangkok, Bangkok, Thailand
Police General Hospital
Bangkok, Bangkok, Thailand
Central Chest Institute of Thailand
Nonthaburi, Changwat Nonthaburi, Thailand
Faculty of Medicine, Prince of Songkla University
Songkhla, Changwat Songkhla, Thailand
Faculty of Medicine, Chiang Mai University,
Chiang Mai, Chiang Mai, Thailand
Bhumibol Adulyadej Hospital
Bangkok, Thailand
Charoen Krung Pracha Rak Hospital
Bangkok, Thailand
Rajavithi Hospital
Bangkok, Thailand
Prapokklao Hospital (Chanthaburi),
Chanthaburi, Thailand
Nakornping Hospital
Chiang Mai, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand
Chonburi Hospital
Chon Buri, Thailand
Queen Savang Vadhana Memorial Hospital
Chon Buri, Thailand
Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand
Lampang Hospital
Lampang, Thailand
Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University
Nakhon Nayok, Thailand
Golden Jubilee Medical Center
Nakhon Pathom, Thailand
Maharat Nakorn Ratchasima Hospital
Nakhon Ratchasima, Thailand
Sawanpracharak Hospital
Nakhon Sawan, Thailand
Faculty of Medicine, Thammasat University, Rangsit Campus
Pathum Thani, Thailand
Buddhachinaraj Hospital
Phitsanulok, Thailand
Faculty of Medicine, Naresuan University
Phitsanulok, Thailand
Vachira Phuket Hospital
Phuket, Thailand
Ratchaburi Hospital
Ratchaburi, Thailand
Sakonnakhon Hospital
Sakon Nakhon, Thailand
Suratthani Hospital
Surat Thani, Thailand
Surin Hospital
Surin, Thailand
Sunpasitthiprasong Hospital
Ubon Ratchathani, Thailand
Udonthani Hospital
Udon Thani, Thailand
Related Publications (1)
Krittayaphong R, Winijkul A, Rungpradubvong V, Apiyasawat S, Phrommintikul A, Chantrarat T, Methavigul K, Chichareon P, Makarawate P, Wongtheptien W, Kaolawanich Y, Lip GYH. The COOL-AF Phase 2 Registry: COhort of Antithrombotic Use and Clinical Outcomes in Atrial Fibrillation Patients. JACC Asia. 2025 Jan 21;5(1):191-202. doi: 10.1016/j.jacasi.2024.10.027. eCollection 2025 Jan.
PMID: 39896253DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rungroj Krittayaphong, MD,FESC,FACC
Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 19, 2024
First Posted
May 2, 2024
Study Start
June 2, 2024
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
May 9, 2025
Record last verified: 2025-05