Clinical trial NCT06396299: COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
Official title: COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
ischemic stroke
major bleeding
death
oral anticoagulant
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Health Systems Research Institute,Thailand
name: The Heart Association of Thailand
First posted: 2024-05-02
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with atrial fibrillation

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.


Eligibility criteria: 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 Criteria:

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

Primary outcomes:
measure: Rate of warfarin and NOACs use
timeFrame: 3 years
measure: Rate of ischemic stroke/TIA
timeFrame: 3 years
measure: Rate of systemic embolism
timeFrame: 3 years
measure: Rate of intracranial hemorrhage
timeFrame: 3 years
measure: Rate of major bleeding
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Meddcine Siriraj Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Bangkok
country: Thailand
facility: Charoen Krung Pracha Rak Hospital
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University,
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Vajira Hospital, Navamindradhiraj University
city: Bangkok
country: Thailand
facility: Phramongkutklao College of Medicine
city: Bangkok
country: Thailand
facility: Police General Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Chanthaburi
country: Thailand
facility: Prapokklao Hospital (Chanthaburi),
city: Chiang Mai
country: Thailand
facility: Faculty of Medicine, Chiang Mai University,
city: Chiang Mai
country: Thailand
facility: Nakornping Hospital
city: Chiang rai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
city: Chon buri
country: Thailand
facility: Chonburi Hospital
city: Chon buri
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
city: Lampang
country: Thailand
facility: Lampang Hospital
city: Nakhon Nayok
country: Thailand
facility: Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University
city: Nakhon Pathom
country: Thailand
facility: Golden Jubilee Medical Center
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakorn Ratchasima Hospital
city: Nakhon Sawan
country: Thailand
facility: Sawanpracharak Hospital
city: Nonthaburi
country: Thailand
facility: Central Chest Institute of Thailand
city: Pathumthani
country: Thailand
facility: Faculty of Medicine, Thammasat University, Rangsit Campus
city: Phitsanulok
country: Thailand
facility: Buddhachinaraj Hospital
city: Phitsanulok
country: Thailand
facility: Faculty of Medicine, Naresuan University
city: Phuket
country: Thailand
facility: Vachira Phuket Hospital
city: Ratchaburi
country: Thailand
facility: Ratchaburi Hospital
city: Sakon nakhon
country: Thailand
facility: Sakonnakhon Hospital
city: Songkla
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
city: Surat thani
country: Thailand
facility: Suratthani Hospital
city: Surin
country: Thailand
facility: Surin Hospital
city: Ubon Ratchathani
country: Thailand
facility: Sunpasitthiprasong Hospital
city: Udon thani
country: Thailand
facility: Udonthani Hospital
Study officials:
affiliation: Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol university
name: Rungroj Krittayaphong, MD,FESC,FACC
role: PRINCIPAL_INVESTIGATOR
References: