Atrial FibrillationNCT06396299
COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
An observational study of Atrial Fibrillation, run by Mahidol University at 33 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 4,000 participants
- Where
- 33 sitesThailand
- Study dates
- 2 Jun 2024to 1 Jun 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with atrial fibrillation
Who may be able to join
- Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.
Who cannot join
- 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.
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- 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
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
Thailand33 sites, 33 recruiting
- Recruiting
Faculty of Meddcine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Faculty of Medicine, Chulalongkorn University,
Bangkok, Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Faculty of Medicine, Vajira Hospital, Navamindradhiraj University
Bangkok, Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Phramongkutklao College of Medicine
Bangkok, Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Police General Hospital
Bangkok, Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Bhumibol Adulyadej Hospital
Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Charoen Krung Pracha Rak Hospital
Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Rajavithi Hospital
Bangkok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Prapokklao Hospital (Chanthaburi),
Chanthaburi
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Faculty of Medicine, Chiang Mai University,
Chiang Mai, Chiang Mai
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Nakornping Hospital
Chiang Mai
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Chiangrai Prachanukroh Hospital
Chiang Rai
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Chonburi Hospital
Chon Buri
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Queen Savang Vadhana Memorial Hospital
Chon Buri
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Faculty of Medicine, Khon Kaen University
Khon Kaen
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Lampang Hospital
Lampang
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University
Nakhon Nayok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Golden Jubilee Medical Center
Nakhon Pathom
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Maharat Nakorn Ratchasima Hospital
Nakhon Ratchasima
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Sawanpracharak Hospital
Nakhon Sawan
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Central Chest Institute of Thailand
Nonthaburi, Changwat Nonthaburi
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Faculty of Medicine, Thammasat University, Rangsit Campus
Pathum Thani
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Buddhachinaraj Hospital
Phitsanulok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Faculty of Medicine, Naresuan University
Phitsanulok
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Vachira Phuket Hospital
Phuket
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Ratchaburi Hospital
Ratchaburi
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Not yet recruiting
Sakonnakhon Hospital
Sakon Nakhon
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Faculty of Medicine, Prince of Songkla University
Songkhla, Changwat Songkhla
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Suratthani Hospital
Surat Thani
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Surin Hospital
Surin
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Sunpasitthiprasong Hospital
Ubon Ratchathani
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
- Recruiting
Udonthani Hospital
Udon Thani
Pontawee Kaewcomdee, B.N.S, 0815594286, pontawee.k@gmail.com
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- No intervention
- Keywords
- atrial fibrillation, ischemic stroke, major bleeding, death, oral anticoagulant
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with atrial fibrillation | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of warfarin and NOACs use
Measured: 3 years
Rate of ischemic stroke/TIA
Measured: 3 years
Rate of systemic embolism
Measured: 3 years
Rate of intracranial hemorrhage
Measured: 3 years
Rate of major bleeding
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start2 Jun 2024
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand, The Heart Association of Thailand
- Responsible party
- Principal investigator, Rungroj Krittayaphong, Mahidol University
- Investigators
- Rungroj Krittayaphong, MD,FESC,FACC, Principal investigator, Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396299
- Sponsor's protocol ID
- COA-CREC103-2023
- Status last verified
- May 2025
- First submitted
- 19 Apr 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39896253
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
- ClinicalTrials.gov ID
- NCT06396299
- Acronym / sponsor ID
- COA-CREC103-2023
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ischemic stroke, major bleeding, death, oral anticoagulant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand, The Heart Association of Thailand
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with atrial fibrillation | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with atrial fibrillation
Key inclusion criteria (1 listed)
- Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients diagnosed with atrial fibrillation |
Primary outcome
Rate of warfarin and NOACs use
Time frame: 3 years
Rate of ischemic stroke/TIA
Time frame: 3 years
Rate of systemic embolism
Time frame: 3 years
Rate of intracranial hemorrhage
Time frame: 3 years
Rate of major bleeding
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Derived from this study: PubMed 39896253Krittayaphong 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rungroj Krittayaphong, MD,FESC,FACC principal investigator
Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Mahidol University at 33 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pontawee Kaewcomdee, B.N.S (0815594286, pontawee.k@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of warfarin and NOACs use (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06396299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.