COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2

Not yet recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: No intervention

• Registration Number: NCT06396299
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-02
• Last Update Posted: 2024-05-02
• Study Start: 2024-06-01
• Primary Completion: 2029-06-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4000

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with atrial fibrillation	No intervention	-

Primary Outcome Measures

Name	Time	Method
Rate of ischemic stroke/TIA	3 years
Rate of warfarin and NOACs use	3 years
Rate of major bleeding	3 years
Rate of intracranial hemorrhage	3 years
Rate of systemic embolism	3 years

Trial Locations

Locations (33)

Faculty of Meddcine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

Charoen Krung Pracha Rak Hospital; 🇹🇭 Bangkok, Thailand

Faculty of Medicine, Chulalongkorn University,; 🇹🇭 Bangkok, Thailand

Faculty of Medicine, Vajira Hospital, Navamindradhiraj University; 🇹🇭 Bangkok, Thailand

Police General Hospital; 🇹🇭 Bangkok, Thailand

Prapokklao Hospital (Chanthaburi),; 🇹🇭 Chanthaburi, Thailand

Chiangrai Prachanukroh Hospital; 🇹🇭 Chiang rai, Thailand

Maharat Nakorn Ratchasima Hospital; 🇹🇭 Nakhon Ratchasima, Thailand

Faculty of Medicine, Naresuan University; 🇹🇭 Phitsanulok, Thailand

Sawanpracharak Hospital; 🇹🇭 Nakhon Sawan, Thailand

Buddhachinaraj Hospital; 🇹🇭 Phitsanulok, Thailand

Phramongkutklao College of Medicine; 🇹🇭 Bangkok, Thailand

Chonburi Hospital; 🇹🇭 Chon buri, Thailand

Faculty of Medicine, Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand

Faculty of Medicine, Chiang Mai University,; 🇹🇭 Chiang Mai, Thailand

Nakornping Hospital; 🇹🇭 Chiang Mai, Thailand

Queen Savang Vadhana Memorial Hospital; 🇹🇭 Chon buri, Thailand

Lampang Hospital; 🇹🇭 Lampang, Thailand

Faculty of Medicine, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand

Faculty of Medicine, HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC) Srinakharinwirot University; 🇹🇭 Nakhon Nayok, Thailand

Golden Jubilee Medical Center; 🇹🇭 Nakhon Pathom, Thailand

Central Chest Institute of Thailand; 🇹🇭 Nonthaburi, Thailand

Faculty of Medicine, Thammasat University, Rangsit Campus; 🇹🇭 Pathumthani, Thailand

Vachira Phuket Hospital; 🇹🇭 Phuket, Thailand

Ratchaburi Hospital; 🇹🇭 Ratchaburi, Thailand

Sakonnakhon Hospital; 🇹🇭 Sakon nakhon, Thailand

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Songkla, Thailand

Suratthani Hospital; 🇹🇭 Surat thani, Thailand

Surin Hospital; 🇹🇭 Surin, Thailand

Sunpasitthiprasong Hospital; 🇹🇭 Ubon Ratchathani, Thailand

Udonthani Hospital; 🇹🇭 Udon thani, Thailand