COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
NCT ID: NCT06396299
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2024-06-02
2030-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients diagnosed with atrial fibrillation
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
100 Years
ALL
No
Sponsors
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Health Systems Research Institute,Thailand
OTHER_GOV
The Heart Association of Thailand
UNKNOWN
Mahidol University
OTHER
Responsible Party
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Rungroj Krittayaphong
Professor
Principal Investigators
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Rungroj Krittayaphong, MD,FESC,FACC
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university
Locations
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Faculty of Meddcine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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COA-CREC103-2023
Identifier Type: -
Identifier Source: org_study_id
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