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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-02

Study Completion Date

2030-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients diagnosed with atrial fibrillation

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Systems Research Institute,Thailand

OTHER_GOV

Sponsor Role collaborator

The Heart Association of Thailand

UNKNOWN

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Rungroj Krittayaphong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Faculty of Medicine, Chulalongkorn University,

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Faculty of Medicine, Vajira Hospital, Navamindradhiraj University

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Phramongkutklao College of Medicine

Bangkok, Bangkok, Thailand

Site Status NOT_YET_RECRUITING

Police General Hospital

Bangkok, Bangkok, Thailand

Site Status NOT_YET_RECRUITING

Central Chest Institute of Thailand

Nonthaburi, Changwat Nonthaburi, Thailand

Site Status RECRUITING

Faculty of Medicine, Prince of Songkla University

Songkhla, Changwat Songkhla, Thailand

Site Status RECRUITING

Faculty of Medicine, Chiang Mai University,

Chiang Mai, Chiang Mai, Thailand

Site Status RECRUITING

Bhumibol Adulyadej Hospital

Bangkok, , Thailand

Site Status RECRUITING

Charoen Krung Pracha Rak Hospital

Bangkok, , Thailand

Site Status RECRUITING

Rajavithi Hospital

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Prapokklao Hospital (Chanthaburi),

Chanthaburi, , Thailand

Site Status NOT_YET_RECRUITING

Nakornping Hospital

Chiang Mai, , Thailand

Site Status NOT_YET_RECRUITING

Chiangrai Prachanukroh Hospital

Chiang Rai, , Thailand

Site Status NOT_YET_RECRUITING

Chonburi Hospital

Chon Buri, , Thailand

Site Status RECRUITING

Queen Savang Vadhana Memorial Hospital

Chon Buri, , Thailand

Site Status RECRUITING

Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Site Status RECRUITING

Lampang Hospital

Lampang, , Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University

Nakhon Nayok, , Thailand

Site Status NOT_YET_RECRUITING

Golden Jubilee Medical Center

Nakhon Pathom, , Thailand

Site Status NOT_YET_RECRUITING

Maharat Nakorn Ratchasima Hospital

Nakhon Ratchasima, , Thailand

Site Status RECRUITING

Sawanpracharak Hospital

Nakhon Sawan, , Thailand

Site Status RECRUITING

Faculty of Medicine, Thammasat University, Rangsit Campus

Pathum Thani, , Thailand

Site Status RECRUITING

Buddhachinaraj Hospital

Phitsanulok, , Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine, Naresuan University

Phitsanulok, , Thailand

Site Status NOT_YET_RECRUITING

Vachira Phuket Hospital

Phuket, , Thailand

Site Status RECRUITING

Ratchaburi Hospital

Ratchaburi, , Thailand

Site Status RECRUITING

Sakonnakhon Hospital

Sakon Nakhon, , Thailand

Site Status NOT_YET_RECRUITING

Suratthani Hospital

Surat Thani, , Thailand

Site Status RECRUITING

Surin Hospital

Surin, , Thailand

Site Status RECRUITING

Sunpasitthiprasong Hospital

Ubon Ratchathani, , Thailand

Site Status RECRUITING

Udonthani Hospital

Udon Thani, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Pontawee Kaewcomdee, B.N.S

Role: CONTACT

0815594286

Rungroj Krittayaphong, MD,FESC,FACC

Role: CONTACT

092-2071250

Facility Contacts

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Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

Pontawee Kaewcomdee, B.N.S

Role: primary

0815594286

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.

Reference Type DERIVED
PMID: 39896253 (View on PubMed)

Other Identifiers

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COA-CREC103-2023

Identifier Type: -

Identifier Source: org_study_id

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