Actively Recruiting
COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
Led by Mahidol University · Updated on 2025-05-09
4000
Participants Needed
33
Research Sites
312 weeks
Total Duration
On this page
Sponsors
M
Mahidol University
Lead Sponsor
H
Health Systems Research Institute,Thailand
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.
You will not qualify if you...
- Ischemic stroke within the past 3 months before enrollment
- Platelet count less than 100,000/mm3 or diagnosis of myeloproliferative disorders, hyperviscosity syndrome, chronic disseminated intravascular coagulation, or antiphospholipid syndrome
- Mechanical prosthetic heart valve
- Rheumatic mitral stenosis
- Participation in research projects with concealed treatments
- Expected life expectancy less than 3 years due to other diseases such as cancer or AIDS
- Pregnancy
- Unable to follow the treatment plan
- No consent to participate
- Hospitalized or discharged from hospital within the past 1 month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Faculty of Meddcine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand, 10700
Actively Recruiting
2
Faculty of Medicine, Chulalongkorn University,
Bangkok, Bangkok, Thailand
Actively Recruiting
3
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Bangkok, Thailand
Actively Recruiting
4
Faculty of Medicine, Vajira Hospital, Navamindradhiraj University
Bangkok, Bangkok, Thailand
Actively Recruiting
5
Phramongkutklao College of Medicine
Bangkok, Bangkok, Thailand
Not Yet Recruiting
6
Police General Hospital
Bangkok, Bangkok, Thailand
Not Yet Recruiting
7
Central Chest Institute of Thailand
Nonthaburi, Changwat Nonthaburi, Thailand
Actively Recruiting
8
Faculty of Medicine, Prince of Songkla University
Songkhla, Changwat Songkhla, Thailand
Actively Recruiting
9
Faculty of Medicine, Chiang Mai University,
Chiang Mai, Chiang Mai, Thailand
Actively Recruiting
10
Bhumibol Adulyadej Hospital
Bangkok, Thailand
Actively Recruiting
11
Charoen Krung Pracha Rak Hospital
Bangkok, Thailand
Actively Recruiting
12
Rajavithi Hospital
Bangkok, Thailand
Not Yet Recruiting
13
Prapokklao Hospital (Chanthaburi),
Chanthaburi, Thailand
Not Yet Recruiting
14
Nakornping Hospital
Chiang Mai, Thailand
Not Yet Recruiting
15
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand
Not Yet Recruiting
16
Chonburi Hospital
Chon Buri, Thailand
Actively Recruiting
17
Queen Savang Vadhana Memorial Hospital
Chon Buri, Thailand
Actively Recruiting
18
Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand
Actively Recruiting
19
Lampang Hospital
Lampang, Thailand
Not Yet Recruiting
20
Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University
Nakhon Nayok, Thailand
Not Yet Recruiting
21
Golden Jubilee Medical Center
Nakhon Pathom, Thailand
Not Yet Recruiting
22
Maharat Nakorn Ratchasima Hospital
Nakhon Ratchasima, Thailand
Actively Recruiting
23
Sawanpracharak Hospital
Nakhon Sawan, Thailand
Actively Recruiting
24
Faculty of Medicine, Thammasat University, Rangsit Campus
Pathum Thani, Thailand
Actively Recruiting
25
Buddhachinaraj Hospital
Phitsanulok, Thailand
Not Yet Recruiting
26
Faculty of Medicine, Naresuan University
Phitsanulok, Thailand
Not Yet Recruiting
27
Vachira Phuket Hospital
Phuket, Thailand
Actively Recruiting
28
Ratchaburi Hospital
Ratchaburi, Thailand
Actively Recruiting
29
Sakonnakhon Hospital
Sakon Nakhon, Thailand
Not Yet Recruiting
30
Suratthani Hospital
Surat Thani, Thailand
Actively Recruiting
31
Surin Hospital
Surin, Thailand
Actively Recruiting
32
Sunpasitthiprasong Hospital
Ubon Ratchathani, Thailand
Actively Recruiting
33
Udonthani Hospital
Udon Thani, Thailand
Actively Recruiting
Research Team
P
Pontawee Kaewcomdee, B.N.S
CONTACT
R
Rungroj Krittayaphong, MD,FESC,FACC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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